Name: Predicase
Price: 199 USD

K-number	K130083
Device name	DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
Applicant	Demetech Corp.
Product code	GAM
Device class	Class II
Decision date	Jul 17, 2013
Decision	Substantially Equivalent
Regulation	878.4493

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Source

View the full FDA submission: accessdata.fda.gov

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DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE

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