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FDA 510(k) Application Details - K032393
Device Classification Name
Stopcock, I.V. Set
More FDA Info for this Device
510(K) Number
K032393
Device Name
Stopcock, I.V. Set
Applicant
ELCAM MEDICAL ACAL
7600 NORTH 15TH STREET
SUITE 217
PHOENIX, AZ 85020 US
Other 510(k) Applications for this Company
Contact
BRUCE WARD
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FMG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2003
Decision Date
09/12/2003
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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