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 |