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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 K791137
Device Name SINGLE USE MONOPOLAR HAND CONTROL PENCIL
Applicant
Davol, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Davol, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/18/1979
Decision Date 07/24/1979
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
Recalls CDRH Recalls
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