The following data is part of a premarket notification filed by Brennen Medical, Inc. with the FDA for Novagel Silicone Gel Sheeting.
| Device ID | K963128 |
| 510k Number | K963128 |
| Device Name: | NOVAGEL SILICONE GEL SHEETING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Mitchell C Muhich |
| Correspondent | Mitchell C Muhich BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1996-12-05 |