FDA 510(k) Application Details - K051762

Device Classification Name Syringe, Antistick

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510(K) Number K051762
Device Name Syringe, Antistick
Applicant SAFETY MEDICAL INTERNATIONAL, INCORPORATED
2055 SPRINT BLVD.
APOPKA, FL 32703 US
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Contact DAVID ZARRILLI
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 06/30/2005
Decision Date 09/23/2005
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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