The following data is part of a premarket notification filed by Ginsberg Scientific, Inc. with the FDA for Mules Sphere Glass (several Sizes).
| Device ID | K895908 |
| 510k Number | K895908 |
| Device Name: | MULES SPHERE GLASS (SEVERAL SIZES) |
| Classification | Implant, Eye Sphere |
| Applicant | GINSBERG SCIENTIFIC, INC. ROUTE 2, BOX 290 Macks Creek, MO 65786 |
| Contact | Edith L Wilson |
| Correspondent | Edith L Wilson GINSBERG SCIENTIFIC, INC. ROUTE 2, BOX 290 Macks Creek, MO 65786 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-10 |
| Decision Date | 1990-01-08 |