Name: Predicase
Price: 199 USD

K-number	K152202
Device name	Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
Applicant	Tni Manufacturing, Inc.
Product code	DQY
Device class	Class II
Decision date	Dec 14, 2015
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm

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