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FDA 510(k) Application Details - K012480
Device Classification Name
Syringe, Balloon Inflation
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510(K) Number
K012480
Device Name
Syringe, Balloon Inflation
Applicant
VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND, FL 33815 US
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Contact
MIKE SAMMON
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Regulation Number
870.1650
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Classification Product Code
MAV
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More FDA Info for this Product Code
Date Received
08/02/2001
Decision Date
01/22/2002
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
N
Expedited Review
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