K082330 is an FDA 510(k) clearance for the PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION, a Dressing, Wound, Drug, submitted by Primary Care Solutions, Inc. (Zephyrhills, US). The FDA issued a Cleared decision on October 9, 2008, 56 days after receiving the submission on August 14, 2008. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K082330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 14, 2008 |
| Decision Date | October 09, 2008 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |