Name: Predicase
Price: 199 USD

K-number	K091087
Device name	MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
Applicant	Surgical Devices, Tyco Healthcare Group LP
Product code	GAM
Device class	Class II
Decision date	Apr 22, 2009
Decision	Substantially Equivalent
Regulation	878.4493

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

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