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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K201617
Device Name TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
Applicant
Schoelly Fiberoptic GmbH
Robert-Bosch-Strasse 1-3
Denzlingen,  DE 79211
Applicant Contact Sandra Baumann
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Avenue
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
FET   GCJ  
Date Received06/15/2020
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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