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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K893243
Device Name INTRA AORTIC BALLOON
Applicant
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Applicant Contact PAUL SCHNEIDER
Correspondent
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Correspondent Contact PAUL SCHNEIDER
Regulation Number870.3535
Classification Product Code
DSP  
Date Received06/01/1989
Decision Date 06/20/1989
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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