The following data is part of a premarket notification filed by Oculinum, Inc. with the FDA for Monopolar Injection Needle Electrode.
| Device ID | K854793 |
| 510k Number | K854793 |
| Device Name: | MONOPOLAR INJECTION NEEDLE ELECTRODE |
| Classification | Preamplifier, Battery-powered, Ophthalmic |
| Applicant | OCULINUM, INC. P. O. BOX 175 Mill Valley, CA 94942 |
| Contact | Scott, M.d. |
| Correspondent | Scott, M.d. OCULINUM, INC. P. O. BOX 175 Mill Valley, CA 94942 |
| Product Code | HLW |
| CFR Regulation Number | 886.1640 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-05 |
| Decision Date | 1986-02-18 |