K810284 is an FDA 510(k) clearance for the AUTOMATIC TEFLON INJECTION SYRINGE. This device is classified as a Syringe, Ent (Class I - General Controls, product code KCP).
Submitted by R. Wolf Medical Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981, 37 days after receiving the submission on February 2, 1981.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.5220.
| 510(k) Number | K810284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1981 |
| Decision Date | March 11, 1981 |
| Days to Decision | 37 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 |