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FDA 510(k) Applications for Medical Device Product Code "PLL"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K180068
Boston Scientific
ORISE Gel
09/28/2018
K150852
COSMO TECHNOLOGIES, LTD.
SIC 8000
09/03/2015
K191254
EndoClot Plus Co., Ltd.
EndoClot
01/30/2020
K191923
GI Supply
EverLift Submucosal Lifting Agent
06/20/2020
K202376
Gi Supply, Inc.
EverLift Submucosal Lifting Agent
09/30/2020
K200071
Micro-Tech (Nanjing) Co., Ltd.
Blue Beacon Submucosal Injectable Solution
11/03/2020
K221385
Ovesco Endoscopy AG
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
08/11/2022
K220434
The Standard Co., Ltd.
Blue Eye (TS-905)
08/12/2022
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