Silon(R) Silicone Thermoplastic Sheeting
FDA 510(k) K945892 · Bio Med Sciences, Inc.
510(k) numberK945892
Submission
- Device name
- Silon(R) Silicone Thermoplastic Sheeting
- Applicant
- Bio Med Sciences, Inc.
Bethlehem, PA, US - Received
- December 2, 1994
- Decision date
- March 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MDA – Elastomer, Silicone, For Scar Management
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4025
- Specialty
- General, Plastic Surgery
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| K112131 | Neodyne DressingMDA · Traditional | Neodyne Biosciences, Inc. | 09/29/2011SE |
| K111733 | Coreleader Scar-DimmerMDA · Traditional | Coreleader Biotech Co., Ltd. | 09/22/2011SE |
| K083718 | Beau RX Scar Care GelMDA · Traditional | Beau RX Solutions, LLC | 01/26/2009SE |
| K053481 | Kelo-Cote SprayMDA · Traditional | Advanced Bio-Technologies, Inc. | 04/14/2006SE |
| K041704 | Newgel and Newgel Plus EMDA · Traditional | Newmedical Technology, Inc. | 10/17/2005SE |
| K040307 | Hanson Scar AdeMDA · Traditional | Hanson Medical, Inc. | 08/12/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | Beiersdorf, Inc. | 06/18/2003SE |
| K024160 | Neosporin Scar SolutionMDA · Traditional | Warner-Lambert Co. | 03/17/2003SE |
| K023678 | Dimisil Scar GelMDA · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 01/23/2003SE |
| K023136 | Oleeva FabricMDA · Special | Bio Med Sciences, Inc. | 10/16/2002SE |
More from Bio Med Sciences, 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 |
| K932214 | Silon Silicone Gel SheetMDA · Traditional | 01/06/1994SE |
| K923150 | Silon Transparent Wound DressingsMGP · Traditional | 08/27/1992SE |
| K912032 | Silon(Tm) Transparent Wound DressingMGP · Traditional | 08/20/1991SE |
Questions and answers
When was Silon(R) Silicone Thermoplastic Sheeting cleared by the FDA?
Silon(R) Silicone Thermoplastic Sheeting (K945892) received a 510(k) decision of Substantially Equivalent on March 3, 1995, 91 days after the submission was received.
What is the product code of K945892?
The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.