ALL PURPOSE ELECTROSURGICAL GENERATOR

Electrosurgical, Cutting & Coagulation & Accessories

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for All Purpose Electrosurgical Generator.

Pre-market Notification Details

Device IDK841483
510k NumberK841483
Device Name:ALL PURPOSE ELECTROSURGICAL GENERATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
ContactCarl A Angles
CorrespondentCarl A Angles
CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-10
Decision Date1984-10-23

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