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FDA 510(k) Application Details - K214053
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K214053
Device Name
Sleeve, Limb, Compressible
Applicant
Mego Afek AC Ltd.
Kibbuts Afek
Kibbuts Afek 3004200 IL
Other 510(k) Applications for this Company
Contact
Ilan Sharon
Other 510(k) Applications for this Contact
Regulation Number
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2021
Decision Date
04/14/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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