The following data is part of a premarket notification filed by Gabris Surgical Corp. with the FDA for Laparoscopic/endoscopic Instruement.
| Device ID | K943989 |
| 510k Number | K943989 |
| Device Name: | LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT |
| Classification | Recorder, Pressure, Intrauterine |
| 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 | HFO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-09-12 |