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FDA 510(k) Application Details - K192059
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K192059
Device Name
Endoscope Channel Accessory
Applicant
United States Endoscopy Group, Inc.
5976 Heisley Road
Mentor, OH 44060 US
Other 510(k) Applications for this Company
Contact
Carroll Martin
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
ODC
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More FDA Info for this Product Code
Date Received
08/01/2019
Decision Date
09/17/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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