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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K091441
Device Name SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
Applicant
Synergetics, Inc.
3845 Corporate Centre Dr.
O' Fallon,  MO  63368
Applicant Contact GARY OLIVEROS
Correspondent
Synergetics, Inc.
3845 Corporate Centre Dr.
O' Fallon,  MO  63368
Correspondent Contact GARY OLIVEROS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/15/2009
Decision Date 10/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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