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510(k) K022880

GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 by Guidant Corp. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2002
Date Received
August 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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