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FDA 510(k) Application Details - K093800
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
KCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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