K241916
- 510(k) number
- K241916
- Device name
- TearRepair Liquid Skin Protectant
- Applicant
- Optmed, Inc. NY · US
- Product code
- KMF — Bandage, Liquid
- Decision date
- 2024-09-27
- Date received
- 2024-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K241916.pdf
Official FDA record: K241916
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.