The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Pro-medical Digital Camera System.
| Device ID | K973430 |
| 510k Number | K973430 |
| Device Name: | KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Contact | Phil Amato |
| Correspondent | Phil Amato EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1998-07-17 |