K853727 is an FDA 510(k) clearance for the KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE). This device is classified as a Case, Contact Lens (Class II - Special Controls, product code LRX).
Submitted by Ryder Intl. Corp. (Arab, US). The FDA issued a Cleared decision on February 7, 1986, 154 days after receiving the submission on September 6, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K853727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1985 |
| Decision Date | February 07, 1986 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | LRX — Case, Contact Lens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |