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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Syringes With Enteral Specific Connectors
510(k) Number K170371
Device Name DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
Applicant
INTERVENE Group Limited
Russell Building, Brunel Science Park, Kingston Lane
Uxbridge,  GB UB8 3PQ
Applicant Contact Homer Trieu
Correspondent
INTERVENE Group Limited
Russell Building, Brunel Science Park, Kingston Lane
Uxbridge,  GB UB8 3PQ
Correspondent Contact Homer Trieu
Regulation Number876.5980
Classification Product Code
PNR  
Date Received02/06/2017
Decision Date 10/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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