The following data is part of a premarket notification filed by G.w.b. Intl., Ltd. with the FDA for Ritleng Bican.lacr.sets/self Thread. Monokas(chg.in Ster.).
| Device ID | K955671 |
| 510k Number | K955671 |
| Device Name: | RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) |
| Classification | Lacrimal Stents And Intubation Sets |
| 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 | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-04 |
| Decision Date | 1996-03-06 |