The following data is part of a premarket notification filed by Advanced Surgical, Inc. with the FDA for Laparoscopic Cholangiography Catheter.
| Device ID | K922190 |
| 510k Number | K922190 |
| Device Name: | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER |
| Classification | Syringe, Piston |
| Applicant | ADVANCED SURGICAL, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Harriet Schwatzman |
| Correspondent | Harriet Schwatzman ADVANCED SURGICAL, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-11 |
| Decision Date | 1992-10-23 |