510(k) K121289
- Device
- LTM-LABAROSCOPIC SURGICAL MESH
- Applicant
- LIFECELL CORP.
- 510(k) number
- K121289
- Product code
- OXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-03
- Date received
- 2012-04-30
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Collagen, 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
- MARK R JAKUBOWSKI
- Address
- One Millennium Way Branchburg NJ US 08876 08876
FDA Registration Numbers#
- 9680579
- 2030598
- 1647098
- 3012102437
- 3005920706
- 3002807561
- 9615742
- 3016823837
- 3009882464
- 3003418325
- 1835959
- 3012547639
- 1000393132
- 3010178296
- 3018094310
- 3013307971
Source Documents#
Other 510(k) Records For Product Code OXK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130817 | LTN - LAPAROSCOPIC SURGICAL MESH | Lifecell Corp. | 2013-04-17 |
Legacy Summary#
summary
FDA Review#
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