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 |