GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS

Tubes, Gastrointestinal (and Accessories)

LAKE REGION MFG., INC.

The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Gastroenterology And Urology Guidewire Modifications.

Pre-market Notification Details

• Device ID: K935198
• 510k Number: K935198
• Device Name: GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318
• Contact: Carl Beaurline
• Correspondent: Carl Beaurline; LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-27
• Decision Date: 1994-09-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704418897	K935198	000
10884521516311	K935198	000
10884521189454	K935198	000