K933526 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 Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on March 10, 1994, 232 days after receiving the submission on July 21, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K933526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1993 |
| Decision Date | March 10, 1994 |
| Days to Decision | 232 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 |