SURGIMEND

Mesh, Surgical

TEI BIOSCIENCES INC.

The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Surgimend.

Pre-market Notification Details

• Device ID: K083898
• 510k Number: K083898
• Device Name: SURGIMEND
• Classification: Mesh, Surgical
• Applicant: TEI BIOSCIENCES INC. 7 ELKINS ST. Boston, MA 02127
• Contact: Kenneth James
• Correspondent: Kenneth James; TEI BIOSCIENCES INC. 7 ELKINS ST. Boston, MA 02127
• Product Code: FTM
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-29
• Decision Date: 2009-02-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780112730	K083898	000
10381780112716	K083898	000
10381780112723	K083898	000
10381780112747	K083898	000
10381780112761	K083898	000
10381780112778	K083898	000
10381780112785	K083898	000
10381780112792	K083898	000
10381780112808	K083898	000
10381780112815	K083898	000
10381780112822	K083898	000
10381780112839	K083898	000
10381780112846	K083898	000
10381780112853	K083898	000
10381780112860	K083898	000
10381780112877	K083898	000
10381780112709	K083898	000
10381780112693	K083898	000
10381780112754	K083898	000
10381780112907	K083898	000
10381780112938	K083898	000
10381780112945	K083898	000
10381780112969	K083898	000
10381780113027	K083898	000
10381780113058	K083898	000
10381780112617	K083898	000
10381780112624	K083898	000
10381780112631	K083898	000
10381780112648	K083898	000
10381780112655	K083898	000
10381780112662	K083898	000
10381780112679	K083898	000
10381780112686	K083898	000
10381780112884	K083898	000
10381780112891	K083898	000
10381780113133	K083898	000
10381780113140	K083898	000
10381780113157	K083898	000
10381780113164	K083898	000
10381780113171	K083898	000
10381780113188	K083898	000
10381780113195	K083898	000
10381780113201	K083898	000
10381780113218	K083898	000
10381780113225	K083898	000
10381780113232	K083898	000
10381780113249	K083898	000
10381780113256	K083898	000
10381780113263	K083898	000
10381780113270	K083898	000
10381780113126	K083898	000
10381780113119	K083898	000
10381780112914	K083898	000
10381780112921	K083898	000
10381780112952	K083898	000
10381780112976	K083898	000
10381780112983	K083898	000
10381780112990	K083898	000
10381780113003	K083898	000
10381780113010	K083898	000
10381780113034	K083898	000
10381780113041	K083898	000
10381780113065	K083898	000
10381780113072	K083898	000
10381780113089	K083898	000
10381780113096	K083898	000
10381780113102	K083898	000
10381780113287	K083898	000