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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K201970
Device Name Schoelly Cystoscopes/Hysteroscopes and Accessories
Applicant
Schoelly Fiberoptic GmbH
Robert-Bosch-Str. 1-3
Denzlingen,  DE D-79211
Applicant Contact Sandra Baumann
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Avenue
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
FAJ  
Date Received07/15/2020
Decision Date 10/08/2020
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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