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FDA 510(k) Application Details - K170371
Device Classification Name
More FDA Info for this Device
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 UB8 3PQ GB
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Contact
Homer Trieu
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/06/2017
Decision Date
10/20/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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