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510(k) K091441

SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET by Synergetics, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2009
Date Received
May 15, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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