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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 K852355
Device Name SINGLE USE ARTHROSCOPY ELECTRODE
Applicant
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Applicant Contact JOHNSON
Correspondent
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Correspondent Contact JOHNSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/03/1985
Decision Date 09/03/1985
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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