Skin Neuveau Scar Treatment
FDA 510(k) K942339 · Puritas Health Care, Inc.
510(k) numberK942339
Submission
- Device name
- Skin Neuveau Scar Treatment
- Applicant
- Puritas Health Care, Inc.
New Milford, CT, US - Received
- May 16, 1994
- Decision date
- November 28, 1994
- 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
Other 510(k)s with product code MDA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K941197 | Silk*Skin Scar TreatmentMDA · Traditional | 08/11/1994SE |
| K935600 | Tracheal Suction CatheterBSY · Traditional | 05/10/1994SESK |
| K935531 | Op-Flex Sump Suction Set with Diffuser TipGBX · Traditional | 05/05/1994SE |
| K940074 | Y-Type Blood Administration SetBRZ · Traditional | 04/21/1994SE |
| K940055 | MultisetBRZ · Traditional | 04/15/1994SE |
| K940054 | Measured Volume Solution Administration SetFPA · Traditional | 04/15/1994SE |
| K935583 | Suction Set, TrachaelBSY · Traditional | 04/11/1994SESK |
| K940070 | Stopcock Intravenous TherapyFMG · Traditional | 04/04/1994SE |
| K940056 | Winged Infusion Set A-Port Vascular Access SystemFPA · Traditional | 04/04/1994SE |
| K935532 | Transfer SetLHI · Traditional | 04/04/1994SE |
Questions and answers
When was Skin Neuveau Scar Treatment cleared by the FDA?
Skin Neuveau Scar Treatment (K942339) received a 510(k) decision of Substantially Equivalent on November 28, 1994, 196 days after the submission was received.
What is the product code of K942339?
The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.