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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 K973164
Device Name HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS
Applicant
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Applicant Contact MARGARET F CROWE
Correspondent
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Correspondent Contact MARGARET F CROWE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/25/1997
Decision Date 11/20/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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