510(k) K011078

MALLEABLE SHAFT CLAMP by Allegiance Healthcare Corp. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2001
Date Received
April 9, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type