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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 K010435
Device Name PHILIPS BV PULSERA/ENDURA
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
VEENPLUIS 4-6
P.O. BOX 10.000
DA BEST,  NL 5680
Applicant Contact MARCIA JONES
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
VEENPLUIS 4-6
P.O. BOX 10.000
DA BEST,  NL 5680
Correspondent Contact MARCIA JONES
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received02/13/2001
Decision Date 03/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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