The following data is part of a premarket notification filed by Proxy Biomedical Ltd. with the FDA for Vitamesh (tm) Blue Lightweight Macroporous Pp Surgical Mesh.
| Device ID | K111121 |
| 510k Number | K111121 |
| Device Name: | VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | PROXY BIOMEDICAL LTD. P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan PROXY BIOMEDICAL LTD. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-21 |
| Decision Date | 2011-05-13 |
| Summary: | summary |