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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 K921384
Device Name PCA ACETABULAR INSERT II
Applicant
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Applicant Contact DENISE E MURPHY
Correspondent
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Correspondent Contact DENISE E MURPHY
Regulation Number888.3320
Classification Product Code
JDL  
Date Received03/23/1992
Decision Date 06/25/1992
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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