510(k) K222740
- Device
- Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
- Applicant
- Speciality Fibres and Materials, Ltd.
- 510(k) number
- K222740
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-21
- Date received
- 2022-09-09
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Nyerngoor Korda Hewitt
- Address
- Galaxy House Binley Industrial Estate, 31 Herald Way Coventry GB CV6 5SF CV6 5SF
FDA Registration Numbers
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Source Documents
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| K250115 | Hemastyl() Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025-10-10 |
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