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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 K944665
Device Name DIB INFUSORS
Applicant
Novacon Corp.
2514 7th Ave. E., Suite 11
St. Paul,  MN  55109
Applicant Contact DAVID P LANG
Correspondent
Novacon Corp.
2514 7th Ave. E., Suite 11
St. Paul,  MN  55109
Correspondent Contact DAVID P LANG
Regulation Number880.5725
Classification Product Code
MEB  
Date Received09/12/1994
Decision Date 02/14/1995
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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