The following data is part of a premarket notification filed by Norwood Abbey , Ltd. with the FDA for Lad (epiture Easytouch), Model Lad-08.
| Device ID | K033962 |
| 510k Number | K033962 |
| Device Name: | LAD (EPITURE EASYTOUCH), MODEL LAD-08 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NORWOOD ABBEY , LTD. 63 WELLS RD. Chelsea Hgts., Victoria, AU 3196 |
| Contact | Paul Clark |
| Correspondent | Paul Clark NORWOOD ABBEY , LTD. 63 WELLS RD. Chelsea Hgts., Victoria, AU 3196 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-02-20 |
| Summary: | summary |