SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
FDA 510(k) clearance K080503 · decided 2008-11-12
Clearance details
- K-number
- K080503
- Device name
- SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
- Applicant
- Advanced Medical Solutions Limited
- Decision
- Substantially Equivalent
- Date received
- 2008-02-25
- Decision date
- 2008-11-12
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Winsford, Cheshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024/S004) | Advanced Medical Solutions Limited | 2023-12-14 |
| LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024/S001) | Advanced Medical Solutions Limited | 2023-07-28 |
| LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024) | Advanced Medical Solutions Limited | 2023-06-02 |