The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Orthomend.
Device ID | K031188 |
510k Number | K031188 |
Device Name: | ORTHOMEND |
Classification | Mesh, Surgical, Polymeric |
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 | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-15 |
Decision Date | 2003-06-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHOMEND 97271990 not registered Live/Pending |
Creative Medical Technologies Inc. 2022-02-17 |
ORTHOMEND 75397080 not registered Dead/Abandoned |
Walker, Robert Terry 1997-11-28 |