The following data is part of a premarket notification filed by Medical Marketing Intl., Inc. with the FDA for Giotto High Tech (h.t.) Mammographic System.
| Device ID | K953902 |
| 510k Number | K953902 |
| Device Name: | GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | MEDICAL MARKETING INTL., INC. 12748 EAST MILLBURN AVE. Baton Rouge, LA 70815 |
| Contact | Edward C Cheek |
| Correspondent | Edward C Cheek MEDICAL MARKETING INTL., INC. 12748 EAST MILLBURN AVE. Baton Rouge, LA 70815 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-18 |
| Decision Date | 1997-03-19 |