The following data is part of a premarket notification filed by G.w.b. Intl., Ltd. with the FDA for Ophta Sil (ritleng Probe And Lacrimal Intubation Set).
| Device ID | K940508 |
| 510k Number | K940508 |
| Device Name: | OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | G.W.B. INTL., LTD. 18 CLARK LN. Sudbury, MA 01776 -2306 |
| Contact | Georg W Bohsack |
| Correspondent | Georg W Bohsack G.W.B. INTL., LTD. 18 CLARK LN. Sudbury, MA 01776 -2306 |
| Product Code | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-04 |
| Decision Date | 1994-05-04 |