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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Parathyroid Autofluorescence Imaging Device
510(k) Number K190891
Device Name Fluobeam LX
Applicant
Fluoptics
7 Parvis Louis Neel, CS 20050
Grenoble Cedex 9,  FR
Applicant Contact Odile Allard
Correspondent
Daniel & Daniel Consulting, LLC
340 Jones Lane
Gardnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number878.4550
Classification Product Code
QDG  
Date Received04/05/2019
Decision Date 07/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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