The following data is part of a premarket notification filed by Arno Intl., Inc. with the FDA for Contact Lenses.
| Device ID | K934859 |
| 510k Number | K934859 |
| Device Name: | CONTACT LENSES |
| Classification | Set, Lens, Trial, Ophthalmic |
| Applicant | ARNO INTL., INC. 330 S. STATE RD. 7, SUITE B PLANTATION, FL 33317 |
| Contact | G. FRANCI |
| Correspondent | G. FRANCI ARNO INTL., INC. 330 S. STATE RD. 7, SUITE B PLANTATION, FL 33317 |
| Product Code | HPC |
| CFR Regulation Number | 886.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1993-12-21 |