FDA 510(k) Application Details - K221385

Device Classification Name

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510(K) Number K221385
Device Name LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
Applicant Ovesco Endoscopy AG
Friedrich-Miescher-Stra▀e 9
Tuebingen 72076 DE
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Contact Marc O. Schurr
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Regulation Number

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Classification Product Code PLL
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Date Received 05/13/2022
Decision Date 08/11/2022
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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