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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K081792
Device Name SPY ANALYSIS TOOLKIT, MODEL SA9000
Applicant
Novadaq Technologies, Inc.
2585 Skymark Ave., Suite 306
Mississauga, Ontario,  CA L4W 4L5
Applicant Contact ALLISON MANNERS
Correspondent
Novadaq Technologies, Inc.
2585 Skymark Ave., Suite 306
Mississauga, Ontario,  CA L4W 4L5
Correspondent Contact ALLISON MANNERS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/25/2008
Decision Date 09/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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