The following data is part of a premarket notification filed by Surgical Structures Ltd. with the FDA for Mesh Gps - Large, Small, Sm, Sm Small.
| Device ID | K092726 |
| 510k Number | K092726 |
| Device Name: | MESH GPS - LARGE, SMALL, SM, SM SMALL |
| Classification | Mesh, Surgical, Deployment Balloon |
| Applicant | SURGICAL STRUCTURES LTD. 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Contact | Shosh Friedman |
| Correspondent | Shosh Friedman SURGICAL STRUCTURES LTD. 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Product Code | OQL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-03 |
| Decision Date | 2010-03-15 |
| Summary: | summary |