The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Catheter, Cholangiogram, Operative.
| Device ID | K772288 |
| 510k Number | K772288 |
| Device Name: | CATHETER, CHOLANGIOGRAM, OPERATIVE |
| Classification | Catheter, Cholangiography |
| Applicant | GESCO INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-12 |
| Decision Date | 1978-01-30 |