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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K192174
Device Name SPY Portable Handheld Imaging (SPY-PHI) System
Applicant
Novadaq Technologies ULC. (now a part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby,  CA V5A 4W2
Applicant Contact Agatha Szeliga
Correspondent
Novadaq Technologies ULC. (now a part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby,  CA V5A 4W2
Correspondent Contact Agatha Szeliga
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Code
IZI  
Date Received08/12/2019
Decision Date 11/15/2019
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
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