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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 K150143
Device Name Normal Saline Flush
Applicant
NURSE ASSIST, INC.
4409 Haltom Rd
Haltom City,  TX  76117
Applicant Contact Brian Cox
Correspondent
NURSE ASSIST, INC.
4409 Haltom Rd
Haltom City,  TX  76117
Correspondent Contact Brian Cox
Regulation Number880.5200
Classification Product Code
NGT  
Date Received01/22/2015
Decision Date 08/31/2015
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
Recalls CDRH Recalls
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