K812444 is an FDA 510(k) clearance for the RADIATION STERILIZATION FOR NEEDLE CNTR. This device is classified as a Needle, Suturing, Disposable (Class I - General Controls, product code GAB).
Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1981, 108 days after receiving the submission on August 28, 1981.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K812444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1981 |
| Decision Date | December 14, 1981 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | GAB — Needle, Suturing, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |