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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K032046
Device Name PHILLIPS OMNIDIAGNOST ELEVA
Applicant
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
Da Best,  NL 5680
Applicant Contact LYNN HARMER
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact LYNN HARMER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/02/2003
Decision Date 07/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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