The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Birtcher Laparoscope And Accessories.
| Device ID | K932987 |
| 510k Number | K932987 |
| Device Name: | BIRTCHER LAPAROSCOPE AND ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Eileen Anderson |
| Correspondent | Eileen Anderson BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-18 |
| Decision Date | 1994-04-25 |