510(k) K092726
- Device
- MESH GPS - LARGE, SMALL, SM, SM SMALL
- Applicant
- SURGICAL STRUCTURES LTD.
- 510(k) number
- K092726
- Product code
- OQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-15
- Date received
- 2009-09-03
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Deployment Balloon
- 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
- SHOSH FRIEDMAN
- Address
- 1914 J.N. Pease Pl. Chalotte NC US 28262 28262
FDA Registration Numbers#
- 3009420598
- 3005636544
- 9616062
- 1213643
- 3007156625
- 1222928
Source Documents#
Legacy Summary#
summary
FDA Review#
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