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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, semi-constrained (metal uncemented acetabular component)
510(K) Number K842518
Device Name UNILOC-CEMENTLESS & SELF TAP ACETABULAR
Applicant
AMERICAN ORTOMED CORP.
p.o. box 3184
72 beechwood avenue
poughkeepsie,  NY  12603
Contact michael m stek
Regulation Number888.3330
Classification Product Code
KWA  
Date Received07/10/1984
Decision Date 01/30/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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