GUIDEWIRE

Accessories, Catheter, G-u

LAKE REGION MFG., INC.

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

Pre-market Notification Details

• Device ID: K921200
• 510k Number: K921200
• Device Name: GUIDEWIRE
• Classification: Accessories, Catheter, G-u
• Applicant: LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318
• Contact: Raul Kohl
• Correspondent: Raul Kohl; LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318
• Product Code: KNY
• CFR Regulation Number: 876.5130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-12
• Decision Date: 1992-09-04