FDA 510(k) Application Details - K093800

Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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510(K) Number K093800
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant ROBINSON MEDSURG LLC
7430 E. PARK MEADOWS DR.
SUITE 300
LONE TREE, CO 80124 US
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Contact RANDOLPH C ROBINSON
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 12/10/2009
Decision Date 06/16/2010
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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