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FDA 510(k) Application Details - K223020
Device Classification Name
More FDA Info for this Device
510(K) Number
K223020
Device Name
VS3-Iridium System (VS3-IR)
Applicant
Visionsense Ltd.
20 Hamagshimim St.
Petach Tikva, Hamerkaz 4934829 IL
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Contact
Guy Wroclawski
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2022
Decision Date
10/28/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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