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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 K152583
Device Name KARL STORZ Endoscopic ICG Imaging System
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVENUE
EL SEGUNDO,  CA  90245
Applicant Contact Mike Samuels
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVENUE
EL SEGUNDO,  CA  90245
Correspondent Contact Winkie Wong
Regulation Number876.1500
Classification Product Code
OWN  
Date Received09/10/2015
Decision Date 05/31/2016
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 No
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