The following data is part of a premarket notification filed by Surgical Innovations Plc with the FDA for Logiflex Laparoscopic Band Positioning Device.
| Device ID | K100109 |
| 510k Number | K100109 |
| Device Name: | LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGICAL INNOVATIONS PLC CLAYTON PARK CLAYTON WOOD RISE Leeds, GB Ls16 6rf |
| Contact | Mike White |
| Correspondent | Mike White SURGICAL INNOVATIONS PLC CLAYTON PARK CLAYTON WOOD RISE Leeds, GB Ls16 6rf |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-14 |
| Decision Date | 2010-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051986011288 | K100109 | 000 |