The following data is part of a premarket notification filed by Medical Scientific, Inc. with the FDA for Evanesce Scar Management System.
| Device ID | K981387 |
| 510k Number | K981387 |
| Device Name: | EVANESCE SCAR MANAGEMENT SYSTEM |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | MEDICAL SCIENTIFIC, INC. 125 JOHN HANCOCK RD. Taunton, MA 02780 |
| Contact | Paul Nardella |
| Correspondent | Paul Nardella MEDICAL SCIENTIFIC, INC. 125 JOHN HANCOCK RD. Taunton, MA 02780 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-16 |
| Decision Date | 1998-06-10 |
| Summary: | summary |