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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 K821951
Device Name DATASCOPE MODEL 83 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 Received06/30/1982
Decision Date 12/21/1982
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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