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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 K213943
Device Name SmartSurgN Visualization System
Applicant
SmartSurgN Incorporated
3150 Almaden Expressway Suite 252
San Jose,  CA  95118
Applicant Contact Cathy Mantor
Correspondent
SmartSurgN Incorporated
3150 Almaden Expressway Suite 252
San Jose,  CA  95118
Correspondent Contact Jocelyn Long
Regulation Number876.1500
Classification Product Code
OWN  
Date Received12/17/2021
Decision Date 11/29/2022
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
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