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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 K170218
Device Name Vesco Medical NRFit Tip Syringes
Applicant
Vesco Medical, LLC
692 N. High St., Suite 205
Columbus,  OH  43215
Applicant Contact Chris O'Keefe
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/25/2017
Decision Date 02/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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