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510(k) K040385

MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 by Quest Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2004
Date Received
February 17, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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