The following data is part of a premarket notification filed by Rudolph Beaver, Inc. with the FDA for Ocu-1.
| Device ID | K875030 |
| 510k Number | K875030 |
| Device Name: | OCU-1 |
| Classification | Cannula, Ophthalmic |
| Applicant | RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
| Contact | Robert P Zoletti |
| Correspondent | Robert P Zoletti RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-07 |
| Decision Date | 1988-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OCU-1 74044932 1661589 Dead/Cancelled |
Becton, Dickinson and Company 1990-04-02 |