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FDA 510(k) Application Details - K003555
Device Classification Name
Syringe, Antistick
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510(K) Number
K003555
Device Name
Syringe, Antistick
Applicant
SPECTRUM BIOTECH, INC.
821 EAST 17TH ST.
N.VANCOUVER, BRITISH COLUMBIA V7L 2X2 CA
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Contact
IAN MCDOUGALL
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Regulation Number
880.5860
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Classification Product Code
MEG
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More FDA Info for this Product Code
Date Received
11/17/2000
Decision Date
08/29/2001
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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