SURGISIS

Mesh, Surgical

COOK BIOTECH, INC.

The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis.

Pre-market Notification Details

• Device ID: K980431
• 510k Number: K980431
• Device Name: SURGISIS
• Classification: Mesh, Surgical
• Applicant: COOK BIOTECH, INC. P.O. BOX 2603, 3055 KENT AVE. West Lafayette, IN 47906
• Contact: Neal E Fearnotm Ph.d
• Correspondent: Neal E Fearnotm Ph.d; COOK BIOTECH, INC. P.O. BOX 2603, 3055 KENT AVE. West Lafayette, IN 47906
• Product Code: FTM
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-02-04
• Decision Date: 1998-05-28
• Summary: summary