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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 K170144
Device Name StentBoost Live
Applicant
Philips Medical Stystems Nederland BV
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact Elaine Alan
Correspondent
Philips Medical Stystems Nederland BV
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact Elaine Alan
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
LLZ  
Date Received01/17/2017
Decision Date 06/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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