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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Pneumatic
510(k) Number K860463
Device Name SINGLE AND DUAL TOURNIQUET CUFF
Applicant
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Applicant Contact JANE JOHNSON
Correspondent
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Correspondent Contact JANE JOHNSON
Regulation Number878.5910
Classification Product Code
KCY  
Date Received02/06/1986
Decision Date 02/25/1986
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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