The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Abc Laparoscopic Handprobe.
| Device ID | K910889 |
| 510k Number | K910889 |
| Device Name: | ABC LAPAROSCOPIC HANDPROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 6110 BOLLINGER RD. San Jose, CA 95129 |
| Contact | William E Mckay |
| Correspondent | William E Mckay BIRTCHER MEDICAL SYSTEMS, INC. 6110 BOLLINGER RD. San Jose, CA 95129 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-04 |
| Decision Date | 1991-08-29 |