K-number	K150607
Device name	Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
Applicant	Osseon, LLC
Product code	NDN
Device class	Class II
Decision date	Apr 9, 2015
Decision	Substantially Equivalent
Regulation	888.3027

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View the full FDA submission: accessdata.fda.gov

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Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml

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