The following data is part of a premarket notification filed by Gabris Surgical Corp. with the FDA for Laparoscopic Surgical Instrument.
| Device ID | K953548 |
| 510k Number | K953548 |
| Device Name: | LAPAROSCOPIC SURGICAL INSTRUMENT |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | GABRIS SURGICAL CORP. 1432 NORTH GREAT NECK RD., SUITE 204 Virginia Beach, VA 23454 |
| Contact | Kenneth A Beltran |
| Correspondent | Kenneth A Beltran GABRIS SURGICAL CORP. 1432 NORTH GREAT NECK RD., SUITE 204 Virginia Beach, VA 23454 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-28 |
| Decision Date | 1995-09-19 |