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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K161883
Device Name CompuFlo Epidural Computer Controlled Anesthesia System
Applicant
Milestone Scientific, Inc.
220 S. Orange Ave.
Livingston,  NJ  07039
Applicant Contact STEPHEN SOLOMON
Correspondent
Milestone Scientific, Inc.
220 S. Orange Ave.
Livingston,  NJ  07039
Correspondent Contact STEPHEN SOLOMON
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/11/2016
Decision Date 06/09/2017
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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