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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 K955834
Device Name SYSTEM 6500 ABC ELECTROSURGICAL UNIT
Applicant
Aspen Laboratories, Inc.
14603 E. Fremont Ave.
Centennial,  CO  80112
Applicant Contact CHARLES M HART
Correspondent
Aspen Laboratories, Inc.
14603 E. Fremont Ave.
Centennial,  CO  80112
Correspondent Contact CHARLES M HART
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/26/1995
Decision Date 07/11/1996
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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