FDA 510(k) Application Details - K222070

Device Classification Name

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510(K) Number K222070
Device Name EndoNaut
Applicant Therenva SAS
74F rue de Paris
Rennes 35000 FR
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Contact Audrey Gallois
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Regulation Number

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Classification Product Code OWB
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Date Received 07/14/2022
Decision Date 10/25/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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