The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Dental Barrier Pac.
Device ID | K884827 |
510k Number | K884827 |
Device Name: | KODAK DENTAL BARRIER PAC |
Classification | Film, Radiographic |
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 | IWZ |
CFR Regulation Number | 892.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-18 |
Decision Date | 1989-01-30 |