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FDA 510(k) Application Details - K210265
Device Classification Name
More FDA Info for this Device
510(K) Number
K210265
Device Name
VS3 Iridium Sytem
Applicant
Visionsense Ltd.
20 Hamagshimim St.
Petach Tikva, Hamerkaz 4934829 IL
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Contact
Nancy Sauer
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Regulation Number
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Classification Product Code
OWN
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Date Received
02/01/2021
Decision Date
11/22/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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