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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K922320
Device Name OMNI CYSTOSCOPE
Applicant
Expanded Optics, Inc.
7382 Bolsa Ave.
Westminster,  CA  92683
Applicant Contact ANITA THIBEAULT
Correspondent
Expanded Optics, Inc.
7382 Bolsa Ave.
Westminster,  CA  92683
Correspondent Contact ANITA THIBEAULT
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received05/18/1992
Decision Date 01/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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