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FDA 510(k) Application Details - K041779
Device Classification Name
Stopcock, I.V. Set
More FDA Info for this Device
510(K) Number
K041779
Device Name
Stopcock, I.V. Set
Applicant
NIPRO MEDICAL CORP.
1384 COPPERFIELD COURT
LEXINGTON, KY 40514-1268 US
Other 510(k) Applications for this Company
Contact
KAELYN B HADLEY
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
07/01/2004
Decision Date
09/21/2004
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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