The following data is part of a premarket notification filed by G.w.b. Intl., Ltd. with the FDA for Ophta Sil {self-threading Monoka (ritleng Type)}.
| Device ID | K950569 |
| 510k Number | K950569 |
| Device Name: | OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} |
| Classification | Plug, Punctum |
| Applicant | G.W.B. INTL., LTD. P.O. BOX 465 Marshfield, MA 02051 -0465 |
| Contact | Anne Bohsack |
| Correspondent | Anne Bohsack G.W.B. INTL., LTD. P.O. BOX 465 Marshfield, MA 02051 -0465 |
| Product Code | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-01 |
| Decision Date | 1995-03-14 |