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FDA 510(k) Application Details - K120084
Device Classification Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
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510(K) Number
K120084
Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR, OH 44060 US
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Contact
ERIC MAYNARD
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Regulation Number
876.1500
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Classification Product Code
OCZ
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More FDA Info for this Product Code
Date Received
01/11/2012
Decision Date
05/30/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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