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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 K941769
Device Name KNEE PROTHESIS
Applicant
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Applicant Contact KEVIN J CROSSEN
Correspondent
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Correspondent Contact KEVIN J CROSSEN
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/11/1994
Decision Date 02/01/1995
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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