510(k) K161939
- Device
- Avance Abdominal Dressing Kit
- Applicant
- Molnlycke Health Care US, LLC
- 510(k) number
- K161939
- Product code
- OXJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-11-17
- Date received
- 2016-07-14
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Megan Bevill
- Address
- 5550 Peachtree Pkwy., Suite 500 Norcross GA US 30092 30092
FDA Registration Numbers#
- 3021632375
- 9615742
- 3009749957
- 2031093
- 3015860534
- 3013111980
- 3002807295
- 3031978586
- 3010383847
- 3003936139
- 3018094310
- 3002807561
- 3017196117
- 3010178296
- 3014479313
- 3024021261
- 9617465
- 3014461810
- 3026560514
- 3017210488
Source Documents#
Other 510(k) Records For Product Code OXJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130852 | AVANCE® FOAM ABDOMINAL DRESSING KIT | Molnlycke Health Care | 2014-04-14 |
Legacy Summary#
summary
FDA Review#
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