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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, Elastomeric
510(k) Number K955849
Device Name DIB INFUSOR
Applicant
NOVACON CORP.
2514 SEVENTH AVENUE EAST
SUITE 11
ST.PAUL,  MN  55109
Applicant Contact DAVID P LANG
Correspondent
NOVACON CORP.
2514 SEVENTH AVENUE EAST
SUITE 11
ST.PAUL,  MN  55109
Correspondent Contact DAVID P LANG
Regulation Number880.5725
Classification Product Code
MEB  
Date Received12/27/1995
Decision Date 08/05/1996
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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