The following data is part of a premarket notification filed by Anexa Biomedical, Inc. with the FDA for Anexa Wound Flush, Usp Sterile Water, And Usp Sterile Normal Saline (0.9% Sodium Chloride) 120 Ml Cup, Usp Sterile Water, And Usp Sterile Normal Saline (0.9% Sodium Chloride) 100ml Bottle, Usp Sterile Water, And Usp Sterile Normal Saline (0.9% Sodium.
| Device ID | K172486 |
| 510k Number | K172486 |
| Device Name: | Anexa Wound Flush, USP Sterile Water, And USP Sterile Normal Saline (0.9% Sodium Chloride) 120 ML Cup, USP Sterile Water, And USP Sterile Normal Saline (0.9% Sodium Chloride) 100mL Bottle, USP Sterile Water, And USP Sterile Normal Saline (0.9% Sodium |
| Classification | Dressing, Wound, Drug |
| Applicant | Anexa Biomedical, Inc. 40423 Air Time Avenue Zephyrhills, FL 33542 |
| Contact | Lenny Budloo |
| Correspondent | Shelly Budloo Anexa Biomedical, Inc. 40423 Air Time Avenue Zephyrhills, FL 33542 |
| 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 | 2017-08-17 |
| Decision Date | 2017-09-21 |
| Summary: | summary |