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FDA 510(k) Application Details - K230028
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K230028
Device Name
Sleeve, Limb, Compressible
Applicant
Cardinal Health200, LLC
3651 Birchwood Drive
Waukegan, IL 60085 US
Other 510(k) Applications for this Company
Contact
Katy Piper
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
01/04/2023
Decision Date
04/03/2023
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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