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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K093800
Device Name ROBINSON MEDSURG QUICKSCREW RACK
Applicant
ROBINSON MEDSURG LLC
7430 E. PARK MEADOWS DR.
SUITE 300
LONE TREE,  CO  80124
Applicant Contact RANDOLPH C ROBINSON
Correspondent
ROBINSON MEDSURG LLC
7430 E. PARK MEADOWS DR.
SUITE 300
LONE TREE,  CO  80124
Correspondent Contact RANDOLPH C ROBINSON
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/10/2009
Decision Date 06/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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