K780599 is an FDA 510(k) clearance for the SYRINGE, EAR & ULCER. This device is classified as a Syringe, Ent (Class I - General Controls, product code KCP).
Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1978, 9 days after receiving the submission on April 10, 1978.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.5220.
| 510(k) Number | K780599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1978 |
| Decision Date | April 19, 1978 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | KCP — Syringe, Ent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.5220 |