LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
FDA 510(k) clearance K120181 · decided 2013-02-14
Clearance details
- K-number
- K120181
- Device name
- LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-20
- Decision date
- 2013-02-14
- Days to decision
- 391 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Pennington, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.