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510(k) K002689

SWABSITE SWABBABLE VALVE, MODEL 245000 by Quest Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2001
Date Received
August 29, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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