The following data is part of a premarket notification filed by Boehringer Ingelheim Pharmaceuticals, Inc. with the FDA for Catapress Tourniguet.
Device ID | K852277 |
510k Number | K852277 |
Device Name: | CATAPRESS TOURNIGUET |
Classification | Tourniquet, Nonpneumatic |
Applicant | BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. 90 EAST RIDGE P.O. BOX 368 Ridgefield, CT 06877 |
Contact | Ruth Wasserman |
Correspondent | Ruth Wasserman BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. 90 EAST RIDGE P.O. BOX 368 Ridgefield, CT 06877 |
Product Code | GAX |
CFR Regulation Number | 878.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-29 |
Decision Date | 1985-06-27 |