K943773 is an FDA 510(k) clearance for the STERILE WATER. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 27, 1995, 209 days after receiving the submission on August 2, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K943773 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1994 |
| Decision Date | February 27, 1995 |
| Days to Decision | 209 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 |