LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES

Electrosurgical, Cutting & Coagulation & Accessories

BIRTCHER MEDICAL SYSTEMS, INC.

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.

Pre-market Notification Details

Device IDK944681
510k NumberK944681
Device Name:LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine,  CA  92718
ContactGerry B Arce
CorrespondentGerry B Arce
BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine,  CA  92718
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-22
Decision Date1994-12-22

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