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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mini Endoscope, Gastroenterology-Urology
510(k) Number K092739
Device Name MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE
Applicant
C-Link Micro Imaging, Inc.
721 Sandoval Way
Hayward,  CA  94544
Applicant Contact MARY P GALLUP
Correspondent
C-Link Micro Imaging, Inc.
721 Sandoval Way
Hayward,  CA  94544
Correspondent Contact MARY P GALLUP
Regulation Number876.1500
Classification Product Code
ODF  
Date Received09/08/2009
Decision Date 01/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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