The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ec-l Cassette.
Device ID | K960834 |
510k Number | K960834 |
Device Name: | KODAK EC-L CASSETTE |
Classification | Accelerator, Linear, Medical |
Applicant | EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
Contact | Daniel J Hayes |
Correspondent | Daniel J Hayes EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-29 |
Decision Date | 1996-05-28 |