The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science - Dental Scanning System.
Device ID | K971894 |
510k Number | K971894 |
Device Name: | KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM |
Classification | Digitizer, Image, Radiological |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
Contact | Judith A Wallace |
Correspondent | Judith A Wallace EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
Product Code | LMA |
CFR Regulation Number | 892.2030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-22 |
Decision Date | 1997-08-20 |
Summary: | summary |