PERMACOL

Mesh, Surgical, Polymeric

TISSUE SCIENCE LABORATORIES, PLC

The following data is part of a premarket notification filed by Tissue Science Laboratories, Plc with the FDA for Permacol.

Pre-market Notification Details

• Device ID: K992556
• 510k Number: K992556
• Device Name: PERMACOL
• Classification: Mesh, Surgical, Polymeric
• Applicant: TISSUE SCIENCE LABORATORIES, PLC 7124 LA JOLLA BLVD. La Jolla, CA
• Contact: Allison F Wren
• Correspondent: Allison F Wren; TISSUE SCIENCE LABORATORIES, PLC 7124 LA JOLLA BLVD. La Jolla, CA
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-07-30
• Decision Date: 2000-02-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884523000238	K992556	000