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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K162880
Device Name TIPCAM 1S 3D System
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact Winkie Wong
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact Winkie Wong
Regulation Number882.1480
Classification Product Code
GWG  
Date Received10/14/2016
Decision Date 03/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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