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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 K003915
Device Name ACCUFUSER; ACCUFUSER PLUS
Applicant
Help Technologies
24312 Armada Dr.
Dana Point,  CA  92629
Applicant Contact ROBERT J BARD
Correspondent
Help Technologies
24312 Armada Dr.
Dana Point,  CA  92629
Correspondent Contact ROBERT J BARD
Regulation Number880.5725
Classification Product Code
MEB  
Date Received12/19/2000
Decision Date 02/15/2001
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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