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FDA 510(k) Application Details - K082587
Device Classification Name
Introducer, Syringe Needle
More FDA Info for this Device
510(K) Number
K082587
Device Name
Introducer, Syringe Needle
Applicant
MEDICAL HOUSE PRODUCTS LIMITED
199 NEWHALL ROAD
SHEFFIELD S9 2QJ GB
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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
09/08/2008
Decision Date
10/02/2008
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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