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FDA 510(k) Application Details - K122417
Device Classification Name
Endoscopic Irrigation/Suction System
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510(K) Number
K122417
Device Name
Endoscopic Irrigation/Suction System
Applicant
THE RUHOF CORP.
611 WEST 5TH STREET
THIRD FLOOR
AUSTIN, TX 78701 US
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Contact
KIMBERLY MCCOY
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Regulation Number
876.1500
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Classification Product Code
OCX
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More FDA Info for this Product Code
Date Received
08/08/2012
Decision Date
05/17/2013
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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