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FDA 510(k) Application Details - K990388
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K990388
Device Name
Set, Administration, Intravascular
Applicant
MYCO MEDICAL SUPPLIES, INC.
101 ROSE VALLEY WOODS DR.
CARY, NC 27513 US
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Contact
SANJIV KUMAR
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
02/08/1999
Decision Date
03/29/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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