Name: Predicase
Price: 199 USD

K-number	K960356
Device name	POSTERIOR ANNULOPLASTY BAND (MODEL 607)
Applicant	The Heart Valve Div. Medtronic Cardiovascular Surg
Product code	KRH
Device class	Class II
Decision date	Aug 27, 1996
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	870.3800

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Source

View the full FDA submission: accessdata.fda.gov

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POSTERIOR ANNULOPLASTY BAND (MODEL 607)

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