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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K191851
Device Name VS3-IR
Applicant
Medtronic
20 Hamagshimim St.
Petach Tikva, Hamerkaz,  IL 49348
Applicant Contact Alex Chanin
Correspondent
Arazy Group Consultants, Inc.
3422 Leonardo Ln.
New Smyrna,  FL  32168
Correspondent Contact Ray Kelly
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Code
GCJ  
Date Received07/10/2019
Decision Date 11/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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