K873388 is an FDA 510(k) clearance for the KEELER CTU CRYO SYSTEM. This device is classified as a Unit, Cryophthalmic (Class II - Special Controls, product code HPS).
Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on November 13, 1987, 81 days after receiving the submission on August 24, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4170.
| 510(k) Number | K873388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1987 |
| Decision Date | November 13, 1987 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPS — Unit, Cryophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4170 |