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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 K851213
Device Name ZWEYMULLER CUP
Original Applicant
ALLO PRO CORP.
post office box 14159
clearwater,  FL  34279
Original Contact sylvia kaplun
Regulation Number888.3330
Classification Product Code
KWA  
Date Received03/26/1985
Decision Date 05/28/1985
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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