K894470 is an FDA 510(k) clearance for the STRYKER TRAUMA TRAY. This device is classified as a Syringe, Irrigating (non Dental) (Class I - General Controls, product code KYZ).
Submitted by Stryker Corp. (Rockville, US). The FDA issued a Cleared decision on August 18, 1989, 31 days after receiving the submission on July 18, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6960.
| 510(k) Number | K894470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1989 |
| Decision Date | August 18, 1989 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KYZ — Syringe, Irrigating (non Dental) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6960 |