K820050 is an FDA 510(k) clearance for the KREMER BLADE GAUGE. This device is classified as a Caliper, Ophthalmic (Class I - General Controls, product code HOE).
Submitted by Accutome, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1982, 47 days after receiving the submission on January 8, 1982.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K820050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 1982 |
| Decision Date | February 24, 1982 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOE — Caliper, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |