K833604 is an FDA 510(k) clearance for the ADJUSTABLE FORK RETRACTOR. This device is classified as a Retractor, Ent (Class I - General Controls, product code KAL).
Submitted by Microtek Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984, 83 days after receiving the submission on October 12, 1983.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K833604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1983 |
| Decision Date | January 03, 1984 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | KAL — Retractor, Ent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |