FDA 510(k) Application Details - K032517

Device Classification Name Syringe, Antistick

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510(K) Number K032517
Device Name Syringe, Antistick
Applicant MEDSAFE TECHNOLOGIES LLC.
1308 MORNINGSIDE PARK DRIVE
ALPHARETTA, GA 30022 US
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Contact JAY MANSOUR
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 08/14/2003
Decision Date 05/18/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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