Silon(Tm) Transparent Wound Dressing
FDA 510(k) K912032 · Bio Med Sciences, Inc.
510(k) numberK912032
Submission
- Device name
- Silon(Tm) Transparent Wound Dressing
- Applicant
- Bio Med Sciences, Inc.
Bethlehem, PA, US - Received
- May 8, 1991
- Decision date
- August 20, 1991
- 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 |
|---|---|---|
| K023136 | Oleeva FabricMDA · Special | 10/16/2002SE |
| K002109 | Oleeva FoamMDA · Traditional | 08/31/2000SE |
| K990042 | Silon Dual-DressFRO · Traditional | 03/19/1999SE |
| K982036 | Silon Scar StripsMDA · Traditional | 08/06/1998SE |
| K952546 | Silon Silicone Textile CompositeMDA · Traditional | 08/07/1995SE |
| K946362 | Silon Silicone Foam SheetingMDA · Traditional | 07/13/1995SE |
| K945892 | Silon(R) Silicone Thermoplastic SheetingMDA · Traditional | 03/03/1995SE |
| K932214 | Silon Silicone Gel SheetMDA · Traditional | 01/06/1994SE |
| K923150 | Silon Transparent Wound DressingsMGP · Traditional | 08/27/1992SE |
Questions and answers
When was Silon(Tm) Transparent Wound Dressing cleared by the FDA?
Silon(Tm) Transparent Wound Dressing (K912032) received a 510(k) decision of Substantially Equivalent on August 20, 1991, 104 days after the submission was received.
What is the product code of K912032?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.