The following data is part of a premarket notification filed by Medicalcv, Inc. with the FDA for Atrilaze Soft Tissue Ablation System.
| Device ID | K040744 |
| 510k Number | K040744 |
| Device Name: | ATRILAZE SOFT TISSUE ABLATION SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL Inver Grove Heights, MN 55077 |
| Contact | Denny Steger |
| Correspondent | Denny Steger 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 | 2004-03-23 |
| Decision Date | 2004-11-30 |
| Summary: | summary |