FDA 510(k) Application Details - K042487

Device Classification Name Syringe, Antistick

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510(K) Number K042487
Device Name Syringe, Antistick
Applicant AVANCA MEDICAL DEVICES, INC.
12200 ACADEMY ROAD NE
# 931
ALBUQUERQUE, NM 87111 US
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Contact FRANK FERGUSON
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 09/13/2004
Decision Date 01/21/2005
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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