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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 K231344
Device Name ActivSight Intraoperative Imaging System
Applicant
Activ Surgical, Inc.
30 Thomson Pl.
Boston,  MA  02110
Applicant Contact Nicholas Child
Correspondent
Activ Surgical, Inc.
30 Thomson Pl.
Boston,  MA  02110
Correspondent Contact Nicholas Child
Regulation Number876.1500
Classification Product Code
OWN  
Date Received05/09/2023
Decision Date 08/02/2023
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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