The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Birtcher Swivel Grip Laparoscopic Probes & Access..
| Device ID | K932779 |
| 510k Number | K932779 |
| Device Name: | BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 1435-J HENRY BRENNAN DR. El Paso, TX 79936 |
| Contact | Eileen M Anderson |
| Correspondent | Eileen M Anderson BIRTCHER MEDICAL SYSTEMS, INC. 1435-J HENRY BRENNAN DR. El Paso, TX 79936 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-08 |
| Decision Date | 1995-03-21 |