Name: Predicase
Price: 199 USD

K-number	K051530
Device name	MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.
Applicant	American Medical Systems, Inc.
Product code	OTN
Device class	Class II
Decision date	Jul 8, 2005
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.

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