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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, mobile
510(k) Number K042368
Device Name PRACTIX CONVENIO
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HIGHWAY
BOTHELL,  WA  98021 -8431
Applicant Contact LYNN HARMER
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HIGHWAY
BOTHELL,  WA  98021 -8431
Correspondent Contact LYNN HARMER
Regulation Number892.1720
Classification Product Code
IZL  
Date Received08/31/2004
Decision Date 10/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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