The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Silk*skin Scar Treatment.
| Device ID | K941197 |
| 510k Number | K941197 |
| Device Name: | SILK*SKIN 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 | 1994-03-14 |
| Decision Date | 1994-08-11 |