LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION

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 Laparoscopic 5mm Abc Probe, Modification.

Pre-market Notification Details

Device IDK925903
510k NumberK925903
Device Name:LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine,  CA  92718
ContactEileen M Anderson
CorrespondentEileen M Anderson
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 Received1992-11-12
Decision Date1992-12-30

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