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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K141601
Device Name IASSIST KNEE SYSTEM
Applicant
ZIMMER CAS
75 QUEEN STREET, SUITE 3300
MONTREAL,  CA H3C 2N6
Applicant Contact CHRISTOPHER MCLEAN
Correspondent
ZIMMER CAS
75 QUEEN STREET, SUITE 3300
MONTREAL,  CA H3C 2N6
Correspondent Contact CHRISTOPHER MCLEAN
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/16/2014
Decision Date 09/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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