FDA 510(k) Application Details - K141759

Device Classification Name Container, Sharps

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510(K) Number K141759
Device Name Container, Sharps
Applicant OAK RIDGE PRODUCTS, LLC
4612 Century Ct
McHenry, IL 60050 US
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Contact CONOR J O'MALLEY
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 07/01/2014
Decision Date 10/24/2014
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 Y
Expedited Review



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