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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 K905654
Device Name ELECTROSURGICAL UNIT WITH ACCESSORIES
Applicant
Aspen Labs
P.O. Box 3936
Englewood,  CO  80155
Applicant Contact JANE JOHNSON
Correspondent
Aspen Labs
P.O. Box 3936
Englewood,  CO  80155
Correspondent Contact JANE JOHNSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/18/1990
Decision Date 03/18/1991
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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