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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
510(k) Number K833991
Device Name BIPOLAR HIP DEVICE
Applicant
ZIMMER
P.O. Box 708
warsaw,  IN  46580
Applicant Contact max sherman
Correspondent
ZIMMER, INC.
P.O. Box 708
warsaw,  IN  46580
Correspondent Contact max sherman
Regulation Number888.3390
Classification Product Code
KWY  
Date Received11/21/1983
Decision Date 01/30/1984
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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