Name: Predicase
Price: 199 USD

K-number	K831949
Device name	PROSTHETIC RINGS #4400 MITRAL & 4500
Applicant	American Edwards Laboratories
Product code	KRH
Device class	Class II
Decision date	Jul 29, 1983
Decision	Substantially Equivalent - Subject to Tracking & PMS
Regulation	870.3800

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Source

View the full FDA submission: accessdata.fda.gov

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PROSTHETIC RINGS #4400 MITRAL & 4500

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