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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
Applicant Contact BARRY M CALVARESE
Correspondent
Advanced Biosearch Assn.
3880 Blackhawk Rd.
Danville,  CA  94506
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
Predetermined Change
Control Plan Authorized		 No
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