FDA 510(k) Application Details - K132681

Device Classification Name Syringe, Antistick

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510(K) Number K132681
Device Name Syringe, Antistick
Applicant SOL-MILLENNIUM MEDICAL, INC.
5415 SUGARLOAF PKWY, STE 2203
LAWRENCEVILLE, GA 30043 US
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Contact JIM BARLEY
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 08/28/2013
Decision Date 05/22/2014
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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