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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 K811372
Device Name MODEL 84 TRANSPORT SYSTEM
Applicant
DATASCOPE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DATASCOPE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.3535
Classification Product Code
DSP  
Date Received05/15/1981
Decision Date 08/03/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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