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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 K853802
Device Name ATS 500 TOURNIQUET
Applicant
ASPEN LABORATORIES, INC.
P.O. BOX 3936
ENGLEWOOD,  CO  80155 -3936
Applicant Contact JOHNSON
Correspondent
ASPEN LABORATORIES, INC.
P.O. BOX 3936
ENGLEWOOD,  CO  80155 -3936
Correspondent Contact JOHNSON
Regulation Number878.5910
Classification Product Code
KCY  
Date Received09/11/1985
Decision Date 10/07/1985
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
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