Name: Predicase
Price: 199 USD

K-number	K150322
Device name	InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
Applicant	Pan Medical , Ltd.
Product code	NDN
Device class	Class II
Decision date	Mar 6, 2015
Decision	Substantially Equivalent
Regulation	888.3027

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Source

View the full FDA submission: accessdata.fda.gov

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InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)

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