Name: Predicase
Price: 199 USD

K-number	K211121
Device name	Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
Applicant	Intera Oncology, Inc.
Product code	PTI
Device class	Class II
Decision date	Oct 14, 2021
Decision	Substantially Equivalent
Regulation	880.5570

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit

Everything you need for a 510(k) submission. Nothing you don't.