The following data is part of a premarket notification filed by Taro Pharmaceuticals, Inc. with the FDA for K-gel.
Device ID | K872128 |
510k Number | K872128 |
Device Name: | K-GEL |
Classification | Lubricant, Patient |
Applicant | TARO PHARMACEUTICALS, INC. 305 SUPERTEST ROAD Downsview, Ont., CA |
Contact | Koehler |
Correspondent | Koehler TARO PHARMACEUTICALS, INC. 305 SUPERTEST ROAD Downsview, Ont., CA |
Product Code | KMJ |
CFR Regulation Number | 880.6375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-02 |
Decision Date | 1987-06-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
K-GEL 75466625 not registered Dead/Abandoned |
Tishcon Corp. 1998-04-13 |
K-GEL 71241690 0226779 Dead/Expired |
1926-12-20 |