The following data is part of a premarket notification filed by Medicalcv, Inc. with the FDA for Atrilaze Laser Ablation System.
| Device ID | K081457 |
| 510k Number | K081457 |
| Device Name: | ATRILAZE LASER ABLATION SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL Inver Grove Heights, MN 55077 |
| Contact | Kirk S Honour |
| Correspondent | Kirk S Honour MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL Inver Grove Heights, MN 55077 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-23 |
| Decision Date | 2008-08-08 |
| Summary: | summary |