The following data is part of a premarket notification filed by Oculinum, Inc. with the FDA for Oculinum Injection Amplifier.
| Device ID | K900279 |
| 510k Number | K900279 |
| Device Name: | OCULINUM INJECTION AMPLIFIER |
| Classification | Preamplifier, Battery-powered, Ophthalmic |
| Applicant | OCULINUM, INC. 901 GRAYSON ST. Berkeley, CA 94710 |
| Contact | Scott, M.d. |
| Correspondent | Scott, M.d. OCULINUM, INC. 901 GRAYSON ST. Berkeley, CA 94710 |
| Product Code | HLW |
| CFR Regulation Number | 886.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-08 |
| Decision Date | 1990-02-09 |