Submission Details
| 510(k) Number | K002025 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2000 |
| Decision Date | October 31, 2000 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
RIGID GAS PERMEABLE CONTACT LENS
Oct 2000
Decision
120d
Days
Class 2
Risk
About This 510(k) Submission
K002025 is an FDA 510(k) clearance for the RIGID GAS PERMEABLE CONTACT LENS, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Polymer Technology (Rochester, US). The FDA issued a Cleared decision on October 31, 2000, 120 days after receiving the submission on July 3, 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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