The following data is part of a premarket notification filed by Medicalcv, Inc. with the FDA for Atrilaze Surgical Ablation System.
Device ID | K060680 |
510k Number | K060680 |
Device Name: | ATRILAZE SURGICAL 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-15 |
Decision Date | 2006-04-11 |
Summary: | summary |