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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 K953382
Device Name ACCUPUMP 901 (MODEL NUMBERS 50 & 100)
Applicant
Pharmaceutical Infusion Technologies, Inc.
6350 Nautilus Dr.
Boulder,  CO  80301
Applicant Contact CHARLES C DUNCAN
Correspondent
Pharmaceutical Infusion Technologies, Inc.
6350 Nautilus Dr.
Boulder,  CO  80301
Correspondent Contact CHARLES C DUNCAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/19/1995
Decision Date 10/17/1995
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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