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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 K833828
Device Name PERCOR 9.5 FR IAB ON DATASCOPE CO2
Applicant
DATASCOPE CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DATASCOPE CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.3535
Classification Product Code
DSP  
Date Received11/02/1983
Decision Date 02/08/1985
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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