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510(k) K030456

VASC-ALERT by Vasc-Alert, LLC — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2003
Date Received
February 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Vasc-Alert, LLC

  • K042566 — VASC-ALERT (November 8, 2004)

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