K981235 is an FDA 510(k) clearance for the OCULOSTAT. This device is classified as a Specula, Ophthalmic (Class I - General Controls, product code HNC).
Submitted by Laser Center Dev. Corp. (St. Louis, US). The FDA issued a Cleared decision on July 15, 1998, 103 days after receiving the submission on April 3, 1998.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K981235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1998 |
| Decision Date | July 15, 1998 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HNC — Specula, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |