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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, Fluoroscopic, Image-Intensified
510(k) Number K050692
Device Name FLXIS
Applicant
Philips Medical Systems North America Co.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Applicant Contact LYNN HARMER
Correspondent
Philips Medical Systems North America Co.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Correspondent Contact LYNN HARMER
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/17/2005
Decision Date 04/08/2005
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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