The following data is part of a premarket notification filed by Gabris Surgical Corp. with the FDA for Laparoscopic Cholecystectomy Instrumentation.
| Device ID | K930716 |
| 510k Number | K930716 |
| Device Name: | LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GABRIS SURGICAL CORP. 7 KESTER DR. Edison, NJ 08817 |
| Contact | Howard K Mann |
| Correspondent | Howard K Mann GABRIS SURGICAL CORP. 7 KESTER DR. Edison, NJ 08817 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-11 |
| Decision Date | 1993-07-23 |