Name: Predicase
Price: 199 USD

K-number	K011055
Device name	THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
Applicant	Go Medical Industries Pty. , Ltd.
Product code	FCM
Device class	Class II
Decision date	Jun 6, 2001
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS

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