The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak T-mat C Film So-119.
Device ID | K843149 |
510k Number | K843149 |
Device Name: | KODAK T-MAT C FILM SO-119 |
Classification | Tissue Graft Of Less Than 6mm |
Applicant | EASTMAN KODAK COMPANY 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LWZ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-10 |
Decision Date | 1984-08-27 |