K-number	K903340
Device name	STERILE URETHRAL CATHETER PROCEDURE KITS
Applicant	Superior Healthcare Group, Inc.
Product code	FCM
Device class	Class II
Decision date	Oct 4, 1990
Decision	Substantially Equivalent — Same Device
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE URETHRAL CATHETER PROCEDURE KITS

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