The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Skin Neuveau Scar Treatment.
| Device ID | K942339 |
| 510k Number | K942339 |
| Device Name: | SKIN NEUVEAU SCAR TREATMENT |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Contact | Thomas P Di Maio |
| Correspondent | Thomas P Di Maio PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-16 |
| Decision Date | 1994-11-28 |