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510(k) K031569

DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX by Datascope Corp. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2003
Date Received
May 20, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Balloon, Intra-Aortic And Control
Device Class
Class II
Regulation Number
870.3535
Review Panel
CV
Submission Type

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