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FDA 510(k) Application Details - K010538
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K010538
Device Name
Set, Administration, Intravascular
Applicant
RD MEDICAL MFG., INC.
CALLE ESCUDERO FINAL, BO.
FULLADOSA
CUELBRA, PR 00775 US
Other 510(k) Applications for this Company
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
02/23/2001
Decision Date
03/30/2001
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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