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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K864632
Device Name P.C.A. MODULAR KNEE SYSTEM
Applicant
HOWMEDICA CORP.
359 VETERANS BLVD.
rutherford,  NJ  07070
Applicant Contact robert e smith
Correspondent
HOWMEDICA CORP.
359 VETERANS BLVD.
rutherford,  NJ  07070
Correspondent Contact robert e smith
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/25/1986
Decision Date 03/06/1987
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
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