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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K103562
Device Name CENTURION PRESSURE INJECTABLE EXTENSION SET
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 Number880.5440
Classification Product Code
FPA  
Date Received12/06/2010
Decision Date 06/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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