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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 K941766
Device Name DIB INFUSOR
Applicant
Novacon Corp.
2514 Seventh Ave. E.
Suite 11
St.Paul,  MN  55109
Applicant Contact DAVID P LANG
Correspondent
Novacon Corp.
2514 Seventh Ave. E.
Suite 11
St.Paul,  MN  55109
Correspondent Contact DAVID P LANG
Regulation Number880.5725
Classification Product Code
MEB  
Date Received04/11/1994
Decision Date 08/05/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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