FLOCATH

Catheter, Urological

RUSCH INTL.

The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Flocath.

Pre-market Notification Details

• Device ID: K000070
• 510k Number: K000070
• Device Name: FLOCATH
• Classification: Catheter, Urological
• Applicant: RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452
• Contact: Karenann J Brozowski
• Correspondent: Karenann J Brozowski; RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452
• Product Code: KOD
• CFR Regulation Number: 876.5130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-01-10
• Decision Date: 2000-02-18

NIH GUDID Devices

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