Transan, Transparent Film Dressing, Transparent Wound Drssing
FDA 510(k) K952449 · Medical Device Development Co.
510(k) numberK952449
Submission
- Device name
- Transan, Transparent Film Dressing, Transparent Wound Drssing
- Applicant
- Medical Device Development Co.
Bangor, PA, US - Received
- May 25, 1995
- Decision date
- August 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K952547 | Coversan, IslesanKMF · Traditional | 08/14/1995SE |
Questions and answers
When was Transan, Transparent Film Dressing, Transparent Wound Drssing cleared by the FDA?
Transan, Transparent Film Dressing, Transparent Wound Drssing (K952449) received a 510(k) decision of Substantially Equivalent on August 7, 1995, 74 days after the submission was received.
What is the product code of K952449?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.