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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 cemented acetabular component)
510(K) Number K934440
Device Name PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES
Applicant
HOWMEDICA CORP.
359 veterans blvd.
rutherford,  NJ  07070
Contact margaret f crowe
Regulation Number888.3320
Classification Product Code
JDL  
Date Received07/06/1993
Decision Date 02/22/1994
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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