K-number	K172214
Device name	Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
Applicant	G-21 S.R.L.
Product code	NDN
Device class	Class II
Decision date	Aug 23, 2017
Decision	Substantially Equivalent
Regulation	888.3027

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Source

View the full FDA submission: accessdata.fda.gov

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Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

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