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FDA 510(k) Application Details - K191923
Device Classification Name
More FDA Info for this Device
510(K) Number
K191923
Device Name
EverLift Submucosal Lifting Agent
Applicant
GI Supply
5069 Ritter Road, Suite 104
Mechanicsburg, PA 17055 US
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Contact
Erika Parry
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Regulation Number
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Classification Product Code
PLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/18/2019
Decision Date
06/20/2020
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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