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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K121498
Device Name PERCUNAV
Applicant
Philips Health Care
49 Spadina Ave.
#310
Toronto,  CA M5V 2J1
Applicant Contact TARA MACKINNON
Correspondent
Philips Health Care
49 Spadina Ave.
#310
Toronto,  CA M5V 2J1
Correspondent Contact TARA MACKINNON
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/21/2012
Decision Date 12/14/2012
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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