The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Sil-k.
Device ID | K914701 |
510k Number | K914701 |
Device Name: | 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 | 1991-10-18 |
Decision Date | 1992-01-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SIL-K 88770969 not registered Live/Pending |
Solutech Pharmaceuticals, LLC 2020-01-23 |
SIL-K 88671404 not registered Live/Pending |
Vivera Pharmaceuticals, Inc. 2019-10-28 |
SIL-K 87041965 5179650 Live/Registered |
Bio Huma Netics, Inc. 2016-05-18 |
SIL-K 74250562 1911019 Dead/Cancelled |
Degania Silicone Ltd. 1992-02-28 |