The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Dt Slides (lac).
Device ID | K913197 |
510k Number | K913197 |
Device Name: | KODAK EKTACHEM DT SLIDES (LAC) |
Classification | Acid, Lactic, Enzymatic Method |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Norman H Geil |
Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | KHP |
CFR Regulation Number | 862.1450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-18 |
Decision Date | 1991-08-26 |