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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti Fog Solution And Accessories, Endoscopy
510(k) Number K925659
Device Name U.C.E.Z. LENS CLEANER KIT
Applicant
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Applicant Contact JILL D ALBRITTON
Correspondent
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Correspondent Contact JILL D ALBRITTON
Regulation Number876.1500
Classification Product Code
OCT  
Date Received10/07/1992
Decision Date 09/17/1993
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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