The following data is part of a premarket notification filed by Miramar Labs, Inc. with the FDA for Miradry System.
Device ID | K180396 |
510k Number | K180396 |
Device Name: | MiraDry System |
Classification | System, Ablation, Microwave And Accessories |
Applicant | Miramar Labs, Inc. 2790 Walsh Avenue Santa Clara, CA 95051 |
Contact | Cynthia Kada |
Correspondent | Cynthia Kada Miramar Labs, Inc. 2790 Walsh Avenue Santa Clara, CA 95051 |
Product Code | NEY |
Subsequent Product Code | MWY |
Subsequent Product Code | OUB |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-13 |
Decision Date | 2018-03-15 |
Summary: | summary |