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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/Polymer, Cemented
510(k) Number K852153
Device Name THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
Applicant
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact CHARLES H LAWYER
Correspondent
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact CHARLES H LAWYER
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/17/1985
Decision Date 08/16/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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