Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
FDA 510(k) clearance K252167 · decided 2025-12-19
Clearance details
- K-number
- K252167
- Device name
- Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
- Applicant
- Qingdao Bright Moon Biomedical Materials Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-10
- Decision date
- 2025-12-19
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Qingdao, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.