Name: Predicase
Price: 199 USD

K-number	K122498
Device name	MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
Applicant	Hologic, Inc.
Product code	HIH
Device class	Class II
Decision date	Sep 10, 2012
Decision	Substantially Equivalent
Regulation	884.1690

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)

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