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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, shoulder, non-constrained, metal/polymer cemented
510(k) Number K982981
Device Name NEW ZIMMER SHOULDER SYSTEM
Applicant
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Applicant Contact laura d williams
Correspondent
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Correspondent Contact laura d williams
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received08/26/1998
Decision Date 12/17/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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