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Technology / MiraDry / Medical device / Hyperhidrosis / Quality management system / Center for Devices and Radiological Health / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Premarket approval / Medicine / Health / Food and Drug Administration


Miramar Labs, Inc miraDry System
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Document Date: 2011-02-17 14:36:36

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City

Way Sunnyvale / Sunnyvale / /

Company

Medical Electrical Systems / Miramnar Labs Inc. / 3 miraDry System Miramar Labs Inc / Miramar Labs Inc / Predicate Device K082819 Miramar Labs / K103014 Trade / Product Code NEY Submitter Miramar Labs Inc. / /

Country

United States / /

Event

Reorganization / FDA Phase / /

/

IndustryTerm

microwave energy / cleared products / microwave therapy equipment / announcements concerning your device / Internet address http /

MedicalCondition

primary axillary hyperhidrosis / generalized hyperhidrosis / hyperhidrosis / axillary hyperhidrosis / persistent hyperhidrosis / /

MedicalTreatment

sham treatment / /

Organization

Orthopedic And Restorative Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / office of Compliance / office of Device Evaluation / office of Surveillance / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division of Surgical / Center for Devices / /

Person

Kathy O'Shaughinessy / Mark N. Melkerson / /

/

Position

General Information Trade Name miraDry System Classification / Vice President / Clinical and Regulatory Affairs / VP / Clinical and Regulatory Affairs Date / General / /

Product

Federal Food / G2 / /

ProvinceOrState

California / /

Technology

radiation / http / Microwave / /

URL

http /

SocialTag