The following data is part of a premarket notification filed by Vigilenz Medical Devices with the FDA for Neuwater Tm (hydrocyntm Aqua).
| Device ID | K142775 |
| 510k Number | K142775 |
| Device Name: | Neuwater TM (HydrocynTM Aqua) |
| Classification | Dressing, Wound, Drug |
| Applicant | Vigilenz Medical Devices 2A, LPBM 2, Taman Perindustrian Bukit Minyak Bukit Minyak, MY 14100 |
| Contact | Shudipta Choudhury |
| Correspondent | Glen Feye ACCURATE CONSULTANTS INC. 3234 Ibis Street San Diego, CA 92103 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-09-26 |
| Decision Date | 2015-02-13 |