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FDA 510(k) Application Details - K210734
Device Classification Name
Dilator, Vessel, For Percutaneous Catheterization
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510(K) Number
K210734
Device Name
Dilator, Vessel, For Percutaneous Catheterization
Applicant
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 US
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Contact
Michael Venezia
Other 510(k) Applications for this Contact
Regulation Number
870.1310
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Classification Product Code
DRE
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More FDA Info for this Product Code
Date Received
03/11/2021
Decision Date
04/06/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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