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FDA 510(k) Application Details - K030260
Device Classification Name
Dilator, Vessel, For Percutaneous Catheterization
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510(K) Number
K030260
Device Name
Dilator, Vessel, For Percutaneous Catheterization
Applicant
VASCUMETRIX, LLC
1058 N. HIGLEY RD. #204
MESA, AZ 85205 US
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Contact
NICK RAIBLE
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Regulation Number
870.1310
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Classification Product Code
DRE
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Date Received
01/24/2003
Decision Date
02/20/2003
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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