The following data is part of a premarket notification filed by Norwood Abbey , Ltd. with the FDA for Lad, Model Lad-01.
| Device ID | K021222 |
| 510k Number | K021222 |
| Device Name: | LAD, MODEL LAD-01 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NORWOOD ABBEY , LTD. 5818 PRINCESS CAROLINE PLACE Leesburg, FL 34748 |
| Contact | Robert Handren |
| Correspondent | Robert Handren NORWOOD ABBEY , LTD. 5818 PRINCESS CAROLINE PLACE Leesburg, FL 34748 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-17 |
| Decision Date | 2003-01-08 |
| Summary: | summary |