Name: Predicase
Price: 199 USD

K-number	K122246
Device name	MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
Applicant	Celleration, Inc.
Product code	NRB
Device class	Class II
Decision date	Aug 13, 2012
Decision	Substantially Equivalent
Regulation	878.4410

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Source

View the full FDA submission: accessdata.fda.gov

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MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

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