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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K191008
Device Name iLab Polaris Multi-Modality Guidance System
Applicant
Boston Scientific Corporation
150 Baytech Dr.
San Jose,  CA  95134
Applicant Contact Mugdha Dongre
Correspondent
Boston Scientific Corporation
150 Baytech Dr.
San Jose,  CA  95134
Correspondent Contact Mugdha Dongre
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DSK   ITX   IYO  
Date Received04/16/2019
Decision Date 07/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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