Submission Details
| 510(k) Number | K000233 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 27, 2000 |
| Decision Date | May 19, 2000 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
MENICON SF-P
May 2000
Decision
113d
Days
Class 2
Risk
About This 510(k) Submission
K000233 is an FDA 510(k) clearance for the MENICON SF-P, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Menicon Co, Ltd. (Wilmington, US). The FDA issued a Cleared decision on May 19, 2000, 113 days after receiving the submission on January 27, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.
Device Classification
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5916 |
Manufacturer
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