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FDA 510(k) Application Details - K093489
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K093489
Device Name
Set, Administration, Intravascular
Applicant
RYMED TECHNOLOGIES, INC.
80 SHELTON TECHNOLOGY CENTER
SHELTON, CT 06484 US
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Contact
JOSEPH AZARY
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
11/10/2009
Decision Date
07/29/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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