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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
510(k) Number K190034
Device Name REMY Medical Therapy Laser System
Applicant
Footdocprenur, LLC
1803 Country Club Dr.
Cherry Hill,  NJ  08003
Applicant Contact David Zuckerman
Correspondent
Braunsolutions
970 S. Dawson Way Unit 14
Aurora,  CO  80012
Correspondent Contact Alexander Braun Henderson
Regulation Number878.4810
Classification Product Code
PDZ  
Subsequent Product Codes
GEX   ILY  
Date Received01/07/2019
Decision Date 05/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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