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FDA 510(k) Application Details - K051248
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K051248
Device Name
Introducer, Catheter
Applicant
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN, PA 19403 US
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Contact
COURTNEY SMITH
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Regulation Number
870.1340
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Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
05/16/2005
Decision Date
10/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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