K896800 is an FDA 510(k) clearance for the IRRIGATION TRAY. This device is classified as a Syringe, Irrigating (non Dental) (Class I - General Controls, product code KYZ).
Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on May 24, 1990, 174 days after receiving the submission on December 1, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6960.
| 510(k) Number | K896800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 01, 1989 |
| Decision Date | May 24, 1990 |
| Days to Decision | 174 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 |