The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Model 775 Bipolar Coagulator.
| Device ID | K850943 |
| 510k Number | K850943 |
| Device Name: | MODEL 775 BIPOLAR COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731 |
| Contact | Donald L Emmons |
| Correspondent | Donald L Emmons BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-07 |
| Decision Date | 1985-05-20 |