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 |