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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K112480
Device Name VIEW 1 IMAGING
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 Number892.2050
Classification Product Code
LLZ  
Date Received08/29/2011
Decision Date 12/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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