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FDA 510(k) Application Details - K960771
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K960771
Device Name
Set, Administration, Intravascular
Applicant
RYMED TECHNOLOGIES, INC.
3110 BLUE SAGE DR.
WOODWARD, OK 73801 US
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Contact
DANA W RYAN
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/1996
Decision Date
12/10/1996
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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