The following data is part of a premarket notification filed by Hoya Surgical Optics, Inc. with the FDA for Hoya Is Injector System.
| Device ID | K081346 |
| 510k Number | K081346 |
| Device Name: | HOYA IS INJECTOR SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVE. Chino Hills, CA 91709 |
| Contact | Steven L Ziemba |
| Correspondent | Steven L Ziemba HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVE. Chino Hills, CA 91709 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-14 |
| Decision Date | 2009-03-23 |