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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, thermal, infusion fluid
510(k) Number K112702
Device Name IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
Applicant
IMPERIAL SURGICAL LTD.
4 INNOVATION DRIVE
DUNDAS,  CA L9H 7P3
Applicant Contact KATHRYN RONALDS
Correspondent
IMPERIAL SURGICAL LTD.
4 INNOVATION DRIVE
DUNDAS,  CA L9H 7P3
Correspondent Contact KATHRYN RONALDS
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received09/16/2011
Decision Date 03/29/2012
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
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