The following data is part of a premarket notification filed by Gabris Surgical Corp. with the FDA for Laparoscopic/endoscopic Instrument.
| Device ID | K944103 |
| 510k Number | K944103 |
| Device Name: | LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GABRIS SURGICAL CORP. 1432 NORTH GREAT NECK RD., SUITE 204 Virginia Beach, VA 23454 |
| Contact | Ken Beltran |
| Correspondent | Ken Beltran GABRIS SURGICAL CORP. 1432 NORTH GREAT NECK RD., SUITE 204 Virginia Beach, VA 23454 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-23 |
| Decision Date | 1994-09-12 |