LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
FDA 510(k) clearance K201016 · decided 2021-01-28
Clearance details
- K-number
- K201016
- Device name
- LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-17
- Decision date
- 2021-01-28
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Huizhou, CN
- Third-party review
- No
- Expedited review
- No
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| LUOFUCON® Antimicrobial Wound Gel (K252028) | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
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Recalls involving this device
No recalls on record reference this clearance.