FOUNDATION

Bone Grafting Material, Synthetic

TERUMO CORP.

The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Foundation.

Pre-market Notification Details

• Device ID: K040783
• 510k Number: K040783
• Device Name: FOUNDATION
• Classification: Bone Grafting Material, Synthetic
• Applicant: TERUMO CORP. 1425 K STREET N.W. SUITE 1100 Washington, DC 20005
• Contact: Keith A Barritt, Esq.
• Correspondent: Keith A Barritt, Esq.; TERUMO CORP. 1425 K STREET N.W. SUITE 1100 Washington, DC 20005
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-03-26
• Decision Date: 2004-10-13
• Summary: summary