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510(k) K982182

FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 by Radi Medical Systems AB — Product Code DXC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 18, 1998
Date Received: June 22, 1998
Clearance Type: Traditional
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

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