The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Degania Silicone Sil-k.
| Device ID | K971482 |
| 510k Number | K971482 |
| Device Name: | DEGANIA SILICONE SIL-K |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden, IL 15130 |
| Contact | Bette Lubin |
| Correspondent | Bette Lubin DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden, IL 15130 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1997-06-24 |
| Summary: | summary |