The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Operative Cholangiogram Catheter.
Device ID | K924981 |
510k Number | K924981 |
Device Name: | OPERATIVE CHOLANGIOGRAM CATHETER |
Classification | Catheter, Cholangiography |
Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
Contact | Kenseth |
Correspondent | Kenseth TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
Product Code | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-01 |
Decision Date | 1993-04-06 |