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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Surgical
510(k) Number K843371
Device Name VALVOTOMY KNIFE
Applicant
Downs Surgical , Ltd.
2500 Park Central Blvd
Decata,  GA  30035 -
Applicant Contact COSTANTINO
Correspondent
Downs Surgical , Ltd.
2500 Park Central Blvd
Decata,  GA  30035 -
Correspondent Contact COSTANTINO
Regulation Number878.4800
Classification Product Code
EMF  
Date Received08/28/1984
Decision Date 10/25/1984
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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