Name: Predicase
Price: 199 USD

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
Product code	PNR
Device class	Class II
Decision date	Oct 20, 2017
Decision	Substantially Equivalent
Regulation	876.5980

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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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

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