K181423 is an FDA 510(k) clearance for the AMSure Sterile Water, and Sterile Normal Saline for Wound Flush. This device is classified as a Dressing, Wound, Drug.
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on September 7, 2018, 99 days after receiving the submission on May 31, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K181423 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2018 |
| Decision Date | September 07, 2018 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |