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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Electrosurgical
510(k) Number K863091
Device Name BICORD BY QMED
Applicant
Qmed, Inc.
3001 W. Kentucky St.
Louisville,  KY  40211
Applicant Contact LARRY D POTTS
Correspondent
Qmed, Inc.
3001 W. Kentucky St.
Louisville,  KY  40211
Correspondent Contact LARRY D POTTS
Regulation Number878.4400
Classification Product Code
HAM  
Date Received08/13/1986
Decision Date 08/29/1986
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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