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 |