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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 K171131
Device Name MHC Standard and NRFit Tip Syringes
Applicant
Mazza Healthcare, LLC
2101 Waukegan Rd.
Suite 208
Bannockburn,  IL  60015
Applicant Contact Michael A. Mazza
Correspondent
Jon Gilbert
1641 Jeurissen Ln.
Chanhassen,  MN  55317
Correspondent Contact Jon Gilbert
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/17/2017
Decision Date 11/08/2017
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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