The following data is part of a premarket notification filed by Leonachi, Inc. with the FDA for Ioves,cortina Club Eyewear,louttesrlg5.
| Device ID | K962107 |
| 510k Number | K962107 |
| Device Name: | IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | LEONACHI, INC. 5943 BISCAYNE BLVD. Miami, FL 33137 |
| Contact | Jorge Ujueta |
| Correspondent | Jorge Ujueta LEONACHI, INC. 5943 BISCAYNE BLVD. Miami, FL 33137 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-31 |
| Decision Date | 1996-06-20 |