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FDA 510(k) Application Details - K953522
Device Classification Name
Syringe, Balloon Inflation
More FDA Info for this Device
510(K) Number
K953522
Device Name
Syringe, Balloon Inflation
Applicant
RYDER INTL. CORP.
1588 ROUTE 130 NORTH
SUITE C-2
NORTH BRUNSWICK, NJ 08902 US
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Contact
PATRICIA W BRADSTREET
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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
07/27/1995
Decision Date
04/17/1996
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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