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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 K183453
Device Name VS3-IR
Applicant
Medtronic
20 Hamagshimim St.
Petach Tikva, Hamerkaz,  IL 49348
Applicant Contact Alex Chanin
Correspondent
Arazy Group Consultants, Inc.
68 Southwood Terrace
Southbury,  CT  06488
Correspondent Contact Ray Kelly
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Codes
GCJ   GWG   HRX  
Date Received12/13/2018
Decision Date 03/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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