K243001
- 510(k) number
- K243001
- Device name
- Sterile Water USP and Sterile 0.9% Normal Saline USP
- Applicant
- Laboratorios Biogalenic S.A. DE C.V. SV
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2025-03-06
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243001.pdf
Official FDA record: K243001
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.