Name: Predicase
Price: 199 USD

K-number	K142808
Device name	CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
Applicant	C.R. Bard, Inc.
Product code	GDW
Device class	Class II
Decision date	Mar 9, 2015
Decision	Substantially Equivalent
Regulation	878.4750

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Source

View the full FDA submission: accessdata.fda.gov

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CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners

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