Name: Predicase
Price: 199 USD

K-number	K042592
Device name	INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
Applicant	American Medical Systems, Inc.
Product code	OTN
Device class	Class II
Decision date	Dec 14, 2004
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304

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