BIPOLAR CARD

Electrosurgical, Cutting & Coagulation & Accessories

NEW ENGLAND SURGICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Bipolar Card.

Pre-market Notification Details

Device IDK831236
510k NumberK831236
Device Name:BIPOLAR CARD
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant NEW ENGLAND SURGICAL INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-15
Decision Date1983-06-02

NIH GUDID Devices

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