The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Laparoscopic 5mm Abc Probe, Modification.
| Device ID | K925903 |
| 510k Number | K925903 |
| Device Name: | LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Eileen M Anderson |
| Correspondent | Eileen M Anderson BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1992-12-30 |