The following data is part of a premarket notification filed by Microsurgeon, Inc. with the FDA for Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100.
Device ID | K070023 |
510k Number | K070023 |
Device Name: | MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 |
Classification | System, Ablation, Microwave And Accessories |
Applicant | MICROSURGEON, INC. 20662 EAST TULIP CIRCLE Montrose, CO 81401 |
Contact | Dudley Harris |
Correspondent | Dudley Harris MICROSURGEON, INC. 20662 EAST TULIP CIRCLE Montrose, CO 81401 |
Product Code | NEY |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-03 |
Decision Date | 2007-08-15 |
Summary: | summary |