The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Lectrosurigical, Cutting And Coagulation And Accessories.
| Device ID | K944681 |
| 510k Number | K944681 |
| Device Name: | LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Gerry B Arce |
| Correspondent | Gerry B Arce 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 | 1994-09-22 |
| Decision Date | 1994-12-22 |