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FDA 510(k) Application Details - K992104
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K992104
Device Name
Set, Administration, Intravascular
Applicant
RD MEDICAL MFG., INC.
CALLE ESCUDERO FINAL, BO.
FULLADOSA
CUELBRA, PR US
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Contact
CARLOS A RODRIGUEZ-GARCIA
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
06/22/1999
Decision Date
08/23/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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