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FDA 510(k) Application Details - K222625
Device Classification Name
More FDA Info for this Device
510(K) Number
K222625
Device Name
Shield System
Applicant
Radiaction Ltd.
10 Hanechoshet St.
Tel Aviv 6971072 IL
Other 510(k) Applications for this Company
Contact
Jonathan Yifat
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
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More FDA Info for this Product Code
Date Received
08/31/2022
Decision Date
09/30/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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