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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K123013
Device Name ENDOSCOPIC INTRODUCER
Applicant
NOVADAQ TECHNOLOGIES, INC.
13155 DELF PLACE, UNIT 250
RICHMOND, BRITISH COLUMBIA,  CA V6V 2A2
Applicant Contact TIM VERSPAGEN
Correspondent
NOVADAQ TECHNOLOGIES, INC.
13155 DELF PLACE, UNIT 250
RICHMOND, BRITISH COLUMBIA,  CA V6V 2A2
Correspondent Contact TIM VERSPAGEN
Regulation Number876.1500
Classification Product Code
FED  
Date Received09/28/2012
Decision Date 03/22/2013
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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