Name: Predicase
Price: 199 USD

K-number	K153611
Device name	Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
Applicant	Ethicon, LLC
Product code	GAM
Device class	Class II
Decision date	Jun 3, 2016
Decision	Substantially Equivalent
Regulation	878.4493

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Source

View the full FDA submission: accessdata.fda.gov

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Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device

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