The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Opeating Microscope Delivery System (omds).
| Device ID | K883213 |
| 510k Number | K883213 |
| Device Name: | NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) |
| Classification | Laser, Ophthalmic |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | Bradley Donaldson |
| Correspondent | Bradley Donaldson NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-29 |
| Decision Date | 1988-09-15 |