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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K211250
Device Name VisionPort System
Applicant
New View Surgical, Inc.
555 Massachusetts Ave., Suite 5
Boston,  MA  02118
Applicant Contact Bryce Klontz
Correspondent
O'Connell Regulatory Consultant, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/26/2021
Decision Date 06/21/2021
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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