FDA 510(k) Application Details - K092739

Device Classification Name Mini Endoscope, Gastroenterology-Urology

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510(K) Number K092739
Device Name Mini Endoscope, Gastroenterology-Urology
Applicant C-LINK MICRO IMAGING, INC
721 SANDOVAL WAY
HAYWARD, CA 94544 US
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Contact MARY P GALLUP
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Regulation Number 876.1500

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Classification Product Code ODF
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Date Received 09/08/2009
Decision Date 01/12/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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