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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K221174
Device Name Telepack +
Applicant
KARL STORZ Endoscopy America, Inc
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact Mario Trujillo
Correspondent
KARL STORZ Endoscopy America, Inc
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Mario Trujillo
Regulation Number876.1500
Classification Product Code
FET  
Date Received04/25/2022
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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