ELECTROSURGERY PENCIL, MODEL 767

Electrosurgical, Cutting & Coagulation & Accessories

BIRTCHER CORP.

The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Electrosurgery Pencil, Model 767.

Pre-market Notification Details

Device IDK860718
510k NumberK860718
Device Name:ELECTROSURGERY PENCIL, MODEL 767
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte,  CA  91731
ContactDonald L Emmons
CorrespondentDonald L Emmons
BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte,  CA  91731
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-26
Decision Date1986-03-24

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