AVANTGARDE

Wheelchair, Mechanical

OTTO BOCK ORTHOPEDIC INDUSTRY, INC.

The following data is part of a premarket notification filed by Otto Bock Orthopedic Industry, Inc. with the FDA for Avantgarde.

Pre-market Notification Details

• Device ID: K951847
• 510k Number: K951847
• Device Name: AVANTGARDE
• Classification: Wheelchair, Mechanical
• Applicant: OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth, MN 55441
• Contact: Mary Kay Buescher
• Correspondent: Mary Kay Buescher; OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth, MN 55441
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-04-20
• Decision Date: 1995-05-12