Device Classification Name |
Instrument For Treatment Of Hyperhidrosis
|
510(k) Number |
K150419 |
Device Name |
miraDry System MD4000 |
Applicant |
MIRAMAR LABS, INC. |
2790 WALSH AVENUE |
SANTA CLARA,
CA
95051
|
|
Applicant Contact |
KATHY O'SHAUGHNESSY |
Correspondent |
MIRAMAR LABS, INC. |
2790 WALSH AVENUE |
SANTA CLARA,
CA
95051
|
|
Correspondent Contact |
KATHY O'SHAUGHNESSY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/18/2015 |
Decision Date | 06/19/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01732497
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|