FDA 510(k) Application Details - K001017

Device Classification Name Syringe, Antistick

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510(K) Number K001017
Device Name Syringe, Antistick
Applicant RETRAX SAFETY SYSTEMS, INC.
1401 BRICKELL AVE SUITE 340
MIAMI, FL 33131 US
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Contact DAVID GARVIN
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 03/29/2000
Decision Date 06/02/2000
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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