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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,  NL 5684PC
Applicant Contact Elaine Alan
Correspondent
Philips Medical Stystems Nederland BV
Veenpluis 4-6
Best,  NL 5684PC
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
Recalls CDRH Recalls
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