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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 K201286
Device Name 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
Applicant
Nurse Assist, LLC
4409 Haltom Rd.
Haltom City,  TX  76117
Applicant Contact Romeo Crisologo
Correspondent
Nurse Assist, LLC
4409 Haltom Rd.
Haltom City,  TX  76117
Correspondent Contact Romeo Crisologo
Regulation Number880.5200
Classification Product Code
NGT  
Date Received05/14/2020
Decision Date 08/11/2020
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
Recalls CDRH Recalls
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