The following data is part of a premarket notification filed by Ls Scientific Inc. D.b.a. Kse Scientific with the FDA for Aqua Care & Accu-rinse, Sterile Water & Sterile Normal Saline.
| Device ID | K170270 |
| 510k Number | K170270 |
| Device Name: | Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline |
| Classification | Dressing, Wound, Drug |
| Applicant | LS Scientific Inc. D.B.A. KSE Scientific 2714 South Miami Boulevard Durham, NC 27703 |
| Contact | Jordan Reynolds |
| Correspondent | Jordan Reynolds LS Scientific Inc. D.B.A. KSE Scientific 2714 South Miami Boulevard Durham, NC 27703 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-06-23 |
| Summary: | summary |