FUSION

Vehicle, Motorized 3-wheeled

BURKE, INC.

The following data is part of a premarket notification filed by Burke, Inc. with the FDA for Fusion.

Pre-market Notification Details

• Device ID: K061912
• 510k Number: K061912
• Device Name: FUSION
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: BURKE, INC. 1800 MERRIAM LN. Kansas City, KS 66106
• Contact: Duwayne E Kramer, Jr.
• Correspondent: Duwayne E Kramer, Jr.; BURKE, INC. 1800 MERRIAM LN. Kansas City, KS 66106
• Product Code: INI
• CFR Regulation Number: 890.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-06
• Decision Date: 2006-08-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B314174781	K061912	000
B314174771	K061912	000
B314150901	K061912	000
B314150851	K061912	000