K934258 is an FDA 510(k) clearance for the SALINE WET DRESSING- STERILE. This device is classified as a Dressing, Wound, Drug.
Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on November 24, 1993, 85 days after receiving the submission on August 31, 1993.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K934258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1993 |
| Decision Date | November 24, 1993 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |