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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 K012631
Device Name REPROCESSED SOFT TISSUE ABLATORS
Applicant
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact DON SELVEY
Correspondent
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact DON SELVEY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/13/2001
Decision Date 12/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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