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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 K221702
Device Name CompuFlo Epidural Computer Controlled Anesthesia System
Applicant
Milestone Scientific, Inc.
425 Eagle Rock Ave.
Suite 403
Roseland,  NJ  07068
Applicant Contact Arjan Haverhals
Correspondent
RQM+
2790 Mosside Blvd.
Pittsburgh,  PA  15146
Correspondent Contact Kevin Go
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/13/2022
Decision Date 02/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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