K872620 is an FDA 510(k) clearance for the SOLOS EYESITE DRAPES. This device is classified as a Drape, Patient, Ophthalmic (Class II - Special Controls, product code HMT).
Submitted by Solos Ophthalmology (Norcross, US). The FDA issued a Cleared decision on July 31, 1987, 25 days after receiving the submission on July 6, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K872620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1987 |
| Decision Date | July 31, 1987 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | HMT — Drape, Patient, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |