Name: Predicase
Price: 199 USD

K-number	K152485
Device name	FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm
Applicant	Ostial Corporation
Product code	LOX
Device class	Class II
Decision date	Feb 16, 2016
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm

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