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FDA 510(k) Application Details - K953676
Device Classification Name
Syringe, Balloon Inflation
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510(K) Number
K953676
Device Name
Syringe, Balloon Inflation
Applicant
NAMIC
PRUYNS ISLAND
GLENS FALLS, NY 12801 US
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Contact
MARY MEAGHER RUBIN
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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
08/07/1995
Decision Date
03/29/1996
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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