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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 K053554
Device Name COMPUFLO
Applicant
MILESTONE SCIENTIFIC, INC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact HOWARD HOLSTEIN
Correspondent
MILESTONE SCIENTIFIC, INC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact HOWARD HOLSTEIN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/20/2005
Decision Date 07/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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