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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, femorotibial, constrained, cemented, metal/polymer
510(k) Number K896048
Device Name S-ROM/NOILES MARK 3
Applicant
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Applicant Contact DEBRA L BING
Correspondent
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Correspondent Contact DEBRA L BING
Regulation Number888.3510
Classification Product Code
KRO  
Date Received10/18/1989
Decision Date 03/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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