The following data is part of a premarket notification filed by Hexcel Medical with the FDA for Hexcelite.
| Device ID | K840416 |
| 510k Number | K840416 |
| Device Name: | HEXCELITE |
| Classification | Bandage, Cast |
| Applicant | HEXCEL MEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITG |
| CFR Regulation Number | 890.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-31 |
| Decision Date | 1984-03-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEXCELITE 76042020 not registered Dead/Abandoned |
Liegeois, Jean-Marie 2000-05-05 |
![]() HEXCELITE 73429809 1304879 Dead/Cancelled |
Hexcel Corporation 1983-06-13 |
![]() HEXCELITE 73069971 1052742 Dead/Cancelled |
Hexcel Corporation 1975-11-24 |