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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K973334
Device Name OZ POWER SYRINGE
Applicant
CARDIOVASCULAR INNOVATIONS
4331 ARCARDY
DALLAS,  TX  75205
Applicant Contact AZAM ANWAR
Correspondent
CARDIOVASCULAR INNOVATIONS
4331 ARCARDY
DALLAS,  TX  75205
Correspondent Contact AZAM ANWAR
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/04/1997
Decision Date 04/03/1998
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
Recalls CDRH Recalls
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