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FDA 510(k) Application Details - K151076
Device Classification Name
Dilator, Vessel, For Percutaneous Catheterization
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510(K) Number
K151076
Device Name
Dilator, Vessel, For Percutaneous Catheterization
Applicant
Summit Access, LLC
14 Inverness Drive East, Suite H-136
Englewood, CO 80112 US
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Contact
Fred Piazza
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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
04/22/2015
Decision Date
05/22/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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