The following data is part of a premarket notification filed by Solos Ophthalmology with the FDA for Solos Eyesite Cap Sleeve.
| Device ID | K872611 |
| 510k Number | K872611 |
| Device Name: | SOLOS EYESITE CAP SLEEVE |
| Classification | Unit, Phacofragmentation |
| Applicant | SOLOS OPHTHALMOLOGY 6191 ATLANTIC BLVD. Norcross, GA 30071 |
| Contact | Stephen Holmes |
| Correspondent | Stephen Holmes SOLOS OPHTHALMOLOGY 6191 ATLANTIC BLVD. Norcross, GA 30071 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-06 |
| Decision Date | 1987-08-10 |