Name: Predicase
Price: 199 USD

K-number	K950344
Device name	HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER
Applicant	Acacia Laboratories, Inc.
Product code	FCM
Device class	Class II
Decision date	Mar 24, 1995
Decision	Substantially Equivalent — Kit Device
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER

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