K862521 is an FDA 510(k) clearance for the BAUSCH & LOMB GR-3 REFRACTOR. This device is classified as a Refractometer, Ophthalmic (Class I - General Controls, product code HKO).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on July 11, 1986, 10 days after receiving the submission on July 1, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.
| 510(k) Number | K862521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1986 |
| Decision Date | July 11, 1986 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | HKO - Refractometer, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1760 |