The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Disposable Supplies Kit For Pea Procedure.
| Device ID | K912384 |
| 510k Number | K912384 |
| Device Name: | DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | Ken Kato |
| Correspondent | Ken Kato NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1991-12-24 |