FDA 510(k) Application Details - K083129

Device Classification Name Container, Sharps

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510(K) Number K083129
Device Name Container, Sharps
Applicant SHARPS COMPLIANCE, INC.
9220 KIRBY DR., SUITE 500
HOUSTON, TX 77054 US
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Contact AL ALADWANI
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 10/22/2008
Decision Date 12/15/2008
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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