AVANCE® FOAM ABDOMINAL DRESSING KIT
FDA 510(k) clearance K130852 · decided 2014-04-14
Clearance details
- K-number
- K130852
- Device name
- AVANCE® FOAM ABDOMINAL DRESSING KIT
- Applicant
- Molnlycke Health Care
- Decision
- Substantially Equivalent
- Date received
- 2013-03-28
- Decision date
- 2014-04-14
- Days to decision
- 382 days
- Clearance type
- Traditional
- Product code
- OXJ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Avance Abdominal Dressing Kit (K161939) | Molnlycke Health Care Us, LLC | 2016-11-17 |
Recalls involving this device
No recalls on record reference this clearance.