The following data is part of a premarket notification filed by Anexa Biomedical, Inc. with the FDA for Anexa Wound Flush, Sterile Water & Sterile Normal Saline.
| Device ID | K161658 |
| 510k Number | K161658 |
| Device Name: | Anexa Wound Flush, Sterile Water & Sterile Normal Saline |
| Classification | Dressing, Wound, Drug |
| Applicant | ANEXA BIOMEDICAL, INC. 40423 AIR TIME AVE Zephyrhills, FL 33542 |
| Contact | Lenny Budloo |
| Correspondent | Yolanda Smith Smith Assoicates 1468 Harwell Avenue Crofton, MD 21114 |
| 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 | 2016-06-16 |
| Decision Date | 2016-09-14 |
| Summary: | summary |