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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K160141
Device Name miraDry System
Applicant
Miramar Labs, Inc.
2790 Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact Kathy O'Shaughnessy
Correspondent
Miramar Labs, Inc.
2790 Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact Kathy O'Shaughnessy
Regulation Number878.4400
Classification Product Code
NEY  
Subsequent Product Codes
MWY   OUB  
Date Received01/21/2016
Decision Date 10/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02312141
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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