The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Mn-r 2000 Cassette.
Device ID | K961453 |
510k Number | K961453 |
Device Name: | KODAK MN-R 2000 CASSETTE |
Classification | Cassette, Radiographic Film |
Applicant | EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
Contact | Henry J Pink |
Correspondent | Henry J Pink EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
Product Code | IXA |
CFR Regulation Number | 892.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-16 |
Decision Date | 1996-07-25 |