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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 K881590
Device Name ADFUSE(TM)
Applicant
Healthtek, Inc.
870 Gold Flat Rd.
P.O. Box 1130
Nevada City,  CA  95959
Applicant Contact JOHN T WRIGHT
Correspondent
Healthtek, Inc.
870 Gold Flat Rd.
P.O. Box 1130
Nevada City,  CA  95959
Correspondent Contact JOHN T WRIGHT
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/13/1988
Decision Date 05/23/1988
Decision Substantially Equivalent (SESE)
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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