The following data is part of a premarket notification filed by Miramar Labs, Inc. with the FDA for Miradry System Md4000.
| Device ID | K150419 |
| 510k Number | K150419 |
| Device Name: | MiraDry System MD4000 |
| Classification | Instrument For Treatment Of Hyperhidrosis |
| Applicant | MIRAMAR LABS, INC. 2790 WALSH AVENUE Santa Clara, CA 95051 |
| Contact | Kathy O'shaughnessy |
| Correspondent | Kathy O'shaughnessy MIRAMAR LABS, INC. 2790 WALSH AVENUE Santa Clara, CA 95051 |
| Product Code | OUB |
| Subsequent Product Code | MWY |
| Subsequent Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-06-19 |
| Summary: | summary |