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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 K901382
Device Name ISOFLO(TM) HIGH PRESSURE INJECTION LINES
Applicant
HEALTHDYNE CARDIOVASCULAR, INC.
45 PARKER ST., SUITE A
IRVINE,  CA  92618 -1658
Applicant Contact BILL WELCH
Correspondent
HEALTHDYNE CARDIOVASCULAR, INC.
45 PARKER ST., SUITE A
IRVINE,  CA  92618 -1658
Correspondent Contact BILL WELCH
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/22/1990
Decision Date 07/19/1990
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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