K943833 is an FDA 510(k) clearance for the STERILE WATER FOR IRRATION. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Orion Life Systems, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on November 1, 1994, 88 days after receiving the submission on August 5, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K943833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1994 |
| Decision Date | November 01, 1994 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | JOL — Catheter And Tip, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |