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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 K080961
Device Name NM APPLICATION SUITE
Applicant
PHILIPS NUCLEAR MEDICINE, INC
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact LORI R PETERSON
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN CHRISTENSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/04/2008
Decision Date 04/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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