TEFGEN-FD

Barrier, Synthetic, Intraoral

AMERICAN CUSTOM MEDICAL, INC.

The following data is part of a premarket notification filed by American Custom Medical, Inc. with the FDA for Tefgen-fd.

Pre-market Notification Details

• Device ID: K935137
• 510k Number: K935137
• Device Name: TEFGEN-FD
• Classification: Barrier, Synthetic, Intraoral
• Applicant: AMERICAN CUSTOM MEDICAL, INC. 3403 73RD ST. Lubbock, TX 79413
• Contact: Bruce G Ruefer
• Correspondent: Bruce G Ruefer; AMERICAN CUSTOM MEDICAL, INC. 3403 73RD ST. Lubbock, TX 79413
• Product Code: NPK
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-28
• Decision Date: 1994-08-15