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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K091799
FOIA Releasable 510(k) K091799
Device Name CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact ANTHONY FRANCALANCIA
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact ANTHONY FRANCALANCIA
Regulation Number888.3030
Classification Product Code
HTN  
Date Received06/17/2009
Decision Date 09/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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