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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 K201743
Device Name ClarifEye R1.0, ClarifEye Needle
Applicant
Philips Medical Systems Nederlands B.V.
Veenpluis 6
Best,  NL 5684PC
Applicant Contact Owen Callaghan
Correspondent
Philips Medical Systems Nederlands B.V.
Veenpluis 6
Best,  NL 5684PC
Correspondent Contact Owen Callaghan
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
HAW   LLZ  
Date Received06/25/2020
Decision Date 02/23/2021
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
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