The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Miniloader(2000).
Device ID | K970059 |
510k Number | K970059 |
Device Name: | KODAK MINILOADER(2000) |
Classification | Processor, Radiographic-film, Automatic |
Applicant | EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Contact | Kenneth Oemcke |
Correspondent | Kenneth Oemcke EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-07 |
Decision Date | 1997-01-27 |