Name: Predicase
Price: 199 USD

K-number	K965111
Device name	STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
Applicant	R. Thomas Grotz, M.D., Inc.
Product code	MBI
Device class	Class II
Decision date	Feb 18, 1997
Decision	Substantially Equivalent
Regulation	888.3040

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View the full FDA submission: accessdata.fda.gov

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STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008

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