ELECTROSURGICAL PENCIL

Electrosurgical, Cutting & Coagulation & Accessories

E & M ENGINEERING, INC.

The following data is part of a premarket notification filed by E & M Engineering, Inc. with the FDA for Electrosurgical Pencil.

Pre-market Notification Details

Device IDK936304
510k NumberK936304
Device Name:ELECTROSURGICAL PENCIL
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant E & M ENGINEERING, INC. 2116 DABNEY RD. SUITE A-5 Richmond,  VA  23230
ContactWinny Chow
CorrespondentWinny Chow
E & M ENGINEERING, INC. 2116 DABNEY RD. SUITE A-5 Richmond,  VA  23230
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-20
Decision Date1994-06-13

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