The following data is part of a premarket notification filed by G.w.b. Intl., Ltd. with the FDA for Ophta Sil(r), Enulceation/evisceration Implants.
| Device ID | K911110 |
| 510k Number | K911110 |
| Device Name: | OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS |
| Classification | Implant, Eye Sphere |
| Applicant | G.W.B. INTL., LTD. P.O. BOX 801 Sudbury, MA 01776 |
| Contact | Georg W Bohsack |
| Correspondent | Georg W Bohsack G.W.B. INTL., LTD. P.O. BOX 801 Sudbury, MA 01776 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-04 |
| Decision Date | 1991-06-18 |