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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument For Treatment Of Hyperhidrosis
510(k) Number K150419
Device Name miraDry System MD4000
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
OUB  
Subsequent Product Codes
MWY   NEY  
Date Received02/18/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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