The following data is part of a premarket notification filed by Surgical Innovations Plc with the FDA for Surgical Retractors.
| Device ID | K112659 |
| 510k Number | K112659 |
| Device Name: | SURGICAL RETRACTORS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGICAL INNOVATIONS PLC CLAYTON WOOD HOUSE, 6 CLAYTON WOOD BANK Leeds, West Yorkshire, GB Ls16 6zq |
| Contact | Stephen Seed |
| Correspondent | Stephen Seed SURGICAL INNOVATIONS PLC CLAYTON WOOD HOUSE, 6 CLAYTON WOOD BANK Leeds, West Yorkshire, GB Ls16 6zq |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-13 |
| Decision Date | 2012-03-09 |
| Summary: | summary |