RUSCH MMG/O'NEIL CATHETER

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

RUSCH, INC.

The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Mmg/o'neil Catheter.

Pre-market Notification Details

• Device ID: K010420
• 510k Number: K010420
• Device Name: RUSCH MMG/O'NEIL CATHETER
• Classification: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
• Applicant: RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096
• Contact: William Slevin
• Correspondent: William Slevin; RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096
• Product Code: FCM
• CFR Regulation Number: 876.5130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-02-12
• Decision Date: 2001-05-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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