Name: Predicase
Price: 199 USD

K-number	K913185
Device name	STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
Applicant	Internacional Farmaceutica, S.A. DE C.V.
Product code	GAQ
Device class	Class II
Decision date	Dec 4, 1991
Decision	Substantially Equivalent
Regulation	878.4495

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT

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