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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K161408
Device Name Compass Cast and MAP
Applicant
Centurion Medical Products Corporation
100 Centurion Way
Williamston,  MI  48895
Applicant Contact MATTHEW K. PRICE
Correspondent
Centurion Medical Products Corporation
100 Centurion Way
Williamston,  MI  48895
Correspondent Contact MATTHEW K. PRICE
Regulation Number870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXG  
Date Received05/20/2016
Decision Date 11/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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