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FDA 510(k) Application Details - K073476
Device Classification Name
Introducer, Syringe Needle
More FDA Info for this Device
510(K) Number
K073476
Device Name
Introducer, Syringe Needle
Applicant
MEDICAL HOUSE (ASI) LIMITED
199, NEWHALL RD.
SHEFFIELD S9 2QJ GB
Other 510(k) Applications for this Company
Contact
ROSE Y GUANG
Other 510(k) Applications for this Contact
Regulation Number
880.6920
More FDA Info for this Regulation Number
Classification Product Code
KZH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2007
Decision Date
03/07/2008
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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