K852057 is an FDA 510(k) clearance for the ASCON SURGICAL INSTRUMENTS. This device is classified as a Forceps, Ophthalmic (Class I - General Controls, product code HNR).
Submitted by Ascon Medical Instruments, Ltd. (Westmont, US). The FDA issued a Cleared decision on June 27, 1985, 49 days after receiving the submission on May 9, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K852057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1985 |
| Decision Date | June 27, 1985 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNR — Forceps, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |