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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sizer, Heart-Valve, Prosthesis
510(k) Number K820887
Device Name MITRAL VALVE ORIFICE SIZER
Applicant
Celtech
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Celtech
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.3945
Classification Product Code
DTI  
Date Received03/30/1982
Decision Date 07/08/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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