Name: Predicase
Price: 199 USD

K-number	K170958
Device name	ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
Applicant	Tricol Biomedical, Inc.
Product code	DXC
Device class	Class II
Decision date	Aug 29, 2017
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm

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