FDA 510(k) Application Details - K122558

Device Classification Name Syringe, Antistick

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510(K) Number K122558
Device Name Syringe, Antistick
Applicant SAFETY SYRINGES, INC.
2875 Loker Ave E
CARLSBAD, CA 92010 US
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Contact SUZANNE RICHARDSON
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 08/22/2012
Decision Date 09/20/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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