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FDA 510(k) Application Details - K954984
Device Classification Name
Stopcock, I.V. Set
More FDA Info for this Device
510(K) Number
K954984
Device Name
Stopcock, I.V. Set
Applicant
DISTRONIC STERILE PRODUCTS, INC.
124 HERITAGE AVE.
PORTSMOUTH, NH 03801-5645 US
Other 510(k) Applications for this Company
Contact
JOYCE MCDOUGALL
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
10/31/1995
Decision Date
01/23/1996
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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