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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 K884656
Device Name DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP
Applicant
Dermacare
7651 National Tpke.
Louisville,  KY  40214
Applicant Contact RYAN M SELL
Correspondent
Dermacare
7651 National Tpke.
Louisville,  KY  40214
Correspondent Contact RYAN M SELL
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/07/1988
Decision Date 11/25/1988
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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