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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 K001159
Device Name HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL
Applicant
Conmedcorp
14603 E. Fremont Ave.
Centennial,  CO  80112
Applicant Contact CHARLES M (MIKE) HART
Correspondent
Conmedcorp
14603 E. Fremont Ave.
Centennial,  CO  80112
Correspondent Contact CHARLES M (MIKE) HART
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/10/2000
Decision Date 06/07/2000
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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