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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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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