Name: Predicase
Price: 199 USD

K-number	K931208
Device name	LOW PROFILE SLEAVE NUT ASSEMBLY
Applicant	Advanced Spine Fixation Systems, Inc.
Product code	KWP
Device class	Class II
Decision date	Mar 28, 1994
Decision	Substantially Equivalent for Some Indications
Regulation	888.3050

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Source

View the full FDA submission: accessdata.fda.gov

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LOW PROFILE SLEAVE NUT ASSEMBLY

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