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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 K103014
Device Name MIRADRY SYSTEM
Applicant
MIRAMAR LABS, INC.
445 indio way
sunnyvale,  CA  94085
Applicant Contact kathy o'shaughnessy
Correspondent
MIRAMAR LABS, INC.
445 indio way
sunnyvale,  CA  94085
Correspodent Contact kathy o'shaughnessy
Regulation Number878.4400
Classification Product Code
OUB  
Subsequent Product Code
NEY  
Date Received10/13/2010
Decision Date 01/28/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Clinical Trials NCT00931359
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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