FDA 510(k) Application Details - K083511

Device Classification Name Container, Sharps

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510(K) Number K083511
Device Name Container, Sharps
Applicant INDUSTRIAL WATER SOLUTIONS, INC
2692 WILLOWLAWN STREET
ROANOKE, VA 24018 US
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Contact THOMAS P STEWART
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 11/26/2008
Decision Date 03/03/2009
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

FDA Source Information for K083511


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