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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 K223885
Device Name HOPKINS Telescopes
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact Jordan Lydia Verla
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact Jordan Lydia Verla
Regulation Number884.1690
Classification Product Code
HIH  
Date Received12/27/2022
Decision Date 09/14/2023
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
Predetermined Change
Control Plan Authorized		 No
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