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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
Applicant
ALLO PRO CORP.
post office box 14159
clearwater,  FL  34279
Applicant Contact sylvia kaplun
Correspondent
ALLO PRO CORP.
post office box 14159
clearwater,  FL  34279
Correspodent Contact sylvia kaplun
Regulation Number888.3330
Classification Product Code
KWA  
Date Received03/26/1985
Decision Date 05/28/1985
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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