Name: Predicase
Price: 199 USD

K-number	K171431
Device name	HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm
Applicant	Biostable Science & Engineering, Inc.
Product code	PST
Device class	Class II
Decision date	Aug 10, 2017
Decision	Substantially Equivalent
Regulation	870.3800

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Source

View the full FDA submission: accessdata.fda.gov

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HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm

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