K852126 is an FDA 510(k) clearance for the ATF 101 TRAIL FRAME. This device is classified as a Frame, Trial, Ophthalmic (Class I - General Controls, product code HPA).
Submitted by Ascon Medical Instruments, Ltd. (Westmont, US). The FDA issued a Cleared decision on June 5, 1985, 21 days after receiving the submission on May 15, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1415.
| 510(k) Number | K852126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 1985 |
| Decision Date | June 05, 1985 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPA — Frame, Trial, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1415 |