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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 K050411
Device Name ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
Original Applicant
ZIMMER, INC.
200 west ohio avenue
p.o. box 10
dover,  OH  44622 0010
Original Contact cindy j dickey
Regulation Number878.5910
Classification Product Code
KCY  
Date Received02/17/2005
Decision Date 09/02/2005
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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