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FDA 510(k) Application Details - K230248
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K230248
Device Name
Clamp, Vascular
Applicant
Vascular Graft Solutions, Ltd.
24 Raoul Wallenberg Street
Tel-Aviv 6971921 IL
Other 510(k) Applications for this Company
Contact
Orit Yarden
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
DXC
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More FDA Info for this Product Code
Date Received
01/30/2023
Decision Date
02/28/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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