Name: Predicase
Price: 199 USD

K-number	K162218
Device name	Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102
Applicant	Nuance Medical, LLC
Product code	MLY
Device class	Class U
Decision date	Nov 22, 2016
Decision	Substantially Equivalent
Regulation	—

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102

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

Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102