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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 K813182
Device Name DATASCOPE MODIFIED #82 IABP SYSTEM
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 Received11/12/1981
Decision Date 03/31/1982
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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