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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 K844943
Device Name WEILL CEMENTLESS THREADED ACETABULAR CUP
Applicant
ADVANCED BIOSEARCH ASSN.
3880 BLACKHAWK RD.
DANVILLE,  CA  94506 -4617
Applicant Contact BARRY M CALVARESE
Correspondent
ADVANCED BIOSEARCH ASSN.
3880 BLACKHAWK RD.
DANVILLE,  CA  94506 -4617
Correspondent Contact BARRY M CALVARESE
Regulation Number888.3330
Classification Product Code
KWA  
Date Received12/20/1984
Decision Date 03/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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