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FDA 510(k) Application Details - K991653
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K991653
Device Name
Set, Administration, Intravascular
Applicant
RYMED TECHNOLOGIES, INC.
19526 EAST LAKE DR.
MIAMI, FL 33015 US
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Contact
AL WEISENBORN
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
05/13/1999
Decision Date
06/24/1999
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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