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FDA 510(k) Application Details - K182003
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K182003
Device Name
Sleeve, Limb, Compressible
Applicant
Mego Afek AC Ltd.
Kibbutz Afek
Kibbutz Afek 3004200 IL
Other 510(k) Applications for this Company
Contact
Reuven Yunger
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
07/26/2018
Decision Date
02/27/2019
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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