The following data is part of a premarket notification filed by X-cel Contacts, A Walman Co. with the FDA for Flexlens And Harrison Post Refractive Surgery (bioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contac.
| Device ID | K030593 |
| 510k Number | K030593 |
| Device Name: | FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | X-CEL CONTACTS, A WALMAN CO. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing X-CEL CONTACTS, A WALMAN CO. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2003-05-30 |
| Summary: | summary |