The following data is part of a premarket notification filed by Ophthalmic Consultants, Inc. with the FDA for I/a (irrigation/aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack, Phacoemulsification Pack, Admiinisn.
| Device ID | K990292 |
| 510k Number | K990292 |
| Device Name: | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | OPHTHALMIC CONSULTANTS, INC. 65 N. MAIN, SUITE 101 PO BOX 154 Tooele, UT 84074 |
| Contact | John E Lincoln |
| Correspondent | John E Lincoln OPHTHALMIC CONSULTANTS, INC. 65 N. MAIN, SUITE 101 PO BOX 154 Tooele, UT 84074 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-29 |
| Decision Date | 1999-11-19 |
| Summary: | summary |