Tecnol Transparent Wound Dressing
FDA 510(k) K952504 · Tecnol Medical Products, Inc.
510(k) numberK952504
Submission
- Device name
- Tecnol Transparent Wound Dressing
- Applicant
- Tecnol Medical Products, Inc.
Fort Worth, TX, US - Received
- May 30, 1995
- Decision date
- July 26, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MGP – Dressing, Wound And Burn, Occlusive
- Device class
- Unclassified
Other 510(k)s with product code MGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012997 | Collatek FoamMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K012995 | Collatek SheetMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K001508 | Laserskin DressingMGP · Traditional | Fidia Advanced Biopolymers Srl | 07/25/2001SE |
| K990079 | Fastseal Chest Wound DressingMGP · Traditional | Greenfield Medical Technologies, Inc. | 12/23/1999SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | Hollister, Inc. | 10/14/1999SE |
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | Dermaphylyx, Inc. | 09/14/1999SE |
| K992005 | Giltech Plus Transparent DressingMGP · Traditional | Giltech Plus, Inc. | 09/03/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | Dermaphylyx, Inc. | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
More from Molnlycke Health Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974068 | PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate…MSH · Traditional | 12/22/1997SE |
| K970448 | PCM 2000; Isolair Apr Model 2735MSH · Traditional | 04/30/1997SE |
| K963564 | Personal Limb Holder (24444-200,300,24444-KIT)FMQ · Traditional | 11/22/1996SE |
| K963559 | Wrparound Limb Holder (24446,24446-350,24447-010,24449-010)FMQ · Traditional | 11/22/1996SE |
| K963552 | Quick Release Limb Holder (24442,24442-050,24442-350)FMQ · Traditional | 11/22/1996SE |
| K963773 | 24457-010 Secure All Pelvic HOLDER/24458-010 Secure All Body BeltFMQ · Traditional | 11/21/1996SE |
| K963563 | Ultracare Vest Style Body Holder with Safety Sleeves, SMALL(24454-010,020,030,040,015,025…FMQ · Traditional | 11/21/1996SE |
| K963561 | Ultra Care Vest Style Body Holder, Small (24455-010,020,030,040,24456-010,020,030,040)FMQ · Traditional | 11/21/1996SE |
| K963557 | System 2 Zippered Body Holder, Small/Medium 24453-010,24453-020,24453-030FMQ · Traditional | 11/21/1996SE |
| K963556 | Secure-All 1-PIECE Body Holder, Small/Medium (24451-010,020,24452-010,020,030)FMQ · Traditional | 11/21/1996SE |
Questions and answers
When was Tecnol Transparent Wound Dressing cleared by the FDA?
Tecnol Transparent Wound Dressing (K952504) received a 510(k) decision of Substantially Equivalent for Some Indications on July 26, 1995, 57 days after the submission was received.
What is the product code of K952504?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.