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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K214080
Device Name Pentaflush
Applicant
Pentaferte Italia S.R.L.
Viale Piane Nocella, 23
Campli Teramo,  IT 64012
Applicant Contact Rosa Di Gioia
Correspondent
Pqe US
12300 Twinbrook Pkwy., Suite 400 4th Floor
Rockville,  MD  20852
Correspondent Contact Luca Giustini
Regulation Number880.5200
Classification Product Code
NGT  
Date Received12/27/2021
Decision Date 07/20/2022
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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