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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K150956
Device Name PINPOINT Endoscopic Fluorescence Imaging System
Applicant
NOVADAQ TECHNOLOGIES, INC.
8329 Eastlake Drive, Unit 101
Burnaby,  CA V5A4W2
Applicant Contact TIM VERSPAGEN
Correspondent
NOVADAQ TECHNOLOGIES, INC.
8329 Eastlake Drive, Unit 101
Burnaby,  CA V5A4W2
Correspondent Contact TIM VERSPAGEN
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
IZI  
Date Received04/09/2015
Decision Date 05/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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