BIPOLAR COAGULATOR #9620/9621

Electrosurgical, Cutting & Coagulation & Accessories

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Bipolar Coagulator #9620/9621.

Pre-market Notification Details

Device IDK823184
510k NumberK823184
Device Name:BIPOLAR COAGULATOR #9620/9621
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-26
Decision Date1982-12-03

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