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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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More FDA Info for this Product Code
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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