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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 K190729
Device Name SPY Portable Handheld Imaging (SPY-PHI) System
Applicant
Novadaq Technologies Ulc. (Now A Part of Stryker)
8329 Eastlake Dr. Unit 101
Burnaby,  CA V5A 4W2
Applicant Contact Agatha Szeliga
Correspondent
Novadaq Technologies Ulc. (Now A Part of Stryker)
8329 Eastlake Dr. Unit 101
Burnaby,  CA V5A 4W2
Correspondent Contact Agatha Szeliga
Regulation Number876.1500
Classification Product Code
OWN  
Date Received03/21/2019
Decision Date 04/19/2019
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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