Hydroderm Breathable Transparent Dressing
FDA 510(k) K935796 · Wilshire Medical Products
510(k) numberK935796
Submission
- Device name
- Hydroderm Breathable Transparent Dressing
- Applicant
- Wilshire Medical Products
Dallas, TX, US - Received
- December 7, 1993
- Decision date
- February 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K946031 | Dermassist(Tm) Hydrogel Saturateed Non Woven DressingMGQ · Traditional | 02/27/1995SE |
| K946030 | Dermassist(Tm) Hydrogel Saturated Gauze DressingMGQ · Traditional | 02/27/1995SE |
| K944333 | Hydroderm Gel Wound DressingMGQ · Traditional | 11/10/1994SN |
| K941216 | Hydroderm Extra Thin Intelligent Hydrocollioid DressingKMF · Traditional | 05/20/1994SN |
| K941149 | Dermaassist Hydrocolloid DressingFRO · Traditional | 05/20/1994SN |
| K941005 | Dermassist(Tm) Xeroform Petrolatum DressingFRO · Traditional | 04/14/1994SN |
| K940076 | Dermassist Wet Dressing, WaterFRO · Traditional | 03/03/1994SE |
| K940044 | Dermassist Wet Dressing, SalineFRO · Traditional | 03/03/1994SE |
| K936234 | Dermassist Oil Emulsion Non-Adhering Wound DressingFRO · Traditional | 03/03/1994SE |
| K936230 | Dermassist Petrolatum Gauze,UspFRO · Traditional | 03/03/1994SE |
Questions and answers
When was Hydroderm Breathable Transparent Dressing cleared by the FDA?
Hydroderm Breathable Transparent Dressing (K935796) received a 510(k) decision of Substantially Equivalent on February 2, 1994, 57 days after the submission was received.
What is the product code of K935796?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.