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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K802605
Device Name ELECTRO SURGICAL TIP CLEANER
Applicant
Concept, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Concept, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/21/1980
Decision Date 11/12/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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