The following data is part of a premarket notification filed by Library Medical, Inc. with the FDA for Soothe & Smooth Scar Care - Silicone Sheeting.
| Device ID | K991312 |
| 510k Number | K991312 |
| Device Name: | SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | LIBRARY MEDICAL, INC. 60 TERENCE DR. Pittsburgh, PA 15236 |
| Contact | Richard A Hartman |
| Correspondent | Richard A Hartman LIBRARY MEDICAL, INC. 60 TERENCE DR. Pittsburgh, PA 15236 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-16 |
| Decision Date | 1999-08-20 |