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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 K180396
Device Name miraDry System
Applicant
Miramar Labs, Inc.
2790 Walsh Avenue
Santa Clara,  CA  95051
Applicant Contact Cynthia Kada
Correspondent
Miramar Labs, Inc.
2790 Walsh Avenue
Santa Clara,  CA  95051
Correspondent Contact Cynthia Kada
Regulation Number878.4400
Classification Product Code
NEY  
Subsequent Product Codes
MWY   OUB  
Date Received02/13/2018
Decision Date 03/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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