Transparent Dressing
FDA 510(k) K943111 · Acutek Adhesive Specialties, Inc.
510(k) numberK943111
Submission
- Device name
- Transparent Dressing
- Applicant
- Acutek Adhesive Specialties, Inc.
Inglewood, CA, US - Received
- June 27, 1994
- Decision date
- September 12, 1994
- 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 |
|---|---|---|
| K974891 | Acutek's Hydrocolloid Wound Dressing, Tib 197013MGP · Traditional | 10/21/1998SE |
| K974892 | Acutek's Hydrocolloid Wound Dressing, Tib 197012MGP · Traditional | 10/13/1998SE |
| K974890 | Acutek's Hydrocolloid Wound Dressing, Tib 997002MGP · Traditional | 10/13/1998SE |
| K962698 | Acutek's ClearpasageLWF · Traditional | 09/09/1996SE |
| K951644 | Acutek's ClearpassageLWF · Traditional | 07/03/1995SE |
Questions and answers
When was Transparent Dressing cleared by the FDA?
Transparent Dressing (K943111) received a 510(k) decision of Substantially Equivalent for Some Indications on September 12, 1994, 77 days after the submission was received.
What is the product code of K943111?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.