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 |