ELECTRO SURGICAL TIP CLEANER

Electrosurgical, Cutting & Coagulation & Accessories

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Electro Surgical Tip Cleaner.

Pre-market Notification Details

Device IDK802605
510k NumberK802605
Device Name:ELECTRO SURGICAL TIP CLEANER
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant CONCEPT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-21
Decision Date1980-11-12

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