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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
Applicant
ZIMMER, INC.
200 WEST OHIO AVENUE
P.O. BOX 10
DOVER,  OH  44622 -0010
Applicant Contact CINDY J DICKEY
Correspondent
ZIMMER, INC.
200 WEST OHIO AVENUE
P.O. BOX 10
DOVER,  OH  44622 -0010
Correspondent Contact CINDY J DICKEY
Regulation Number878.5910
Classification Product Code
KCY  
Date Received02/17/2005
Decision Date 09/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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