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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 K182696
Device Name Telepack X LED
Applicant
KARL STORZ Endoscopy-America, Inc
2151 E. Grand Ave
EI Segundo,  CA  90245
Applicant Contact Winkie Wong
Correspondent
KARL STORZ Endoscopy-America, Inc
2151 E. Grand Ave
EI Segundo,  CA  90245
Correspondent Contact Winkie Wong
Regulation Number876.1500
Classification Product Code
FET  
Date Received09/27/2018
Decision Date 11/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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