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THE ARTAS RESTORATION ROBOTICS, INC. SYSTEM FROM RESTORATION ROBOTICS 5 10(k) PREMARKET NOTIFICATION
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Document Date: 2011-05-30 00:44:04


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File Size: 196,19 KB

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City

Sunnyvale / Mountain View / /

Company

HUMAN SERVICES Restoration Robotics Inc. / PREMARKET NOTIFICATION RESTORATION ROBOTICS INC. / Medicamat S.A. / Experien Group LLC / Integrated Surgical Systems Inc. / Medicamnat S.A. / Restoration Robotics Inc. / ARTAS RESTORATION ROBOTICS INC. / K103428 Trade / Regulatory Affairs Experien Group LLC / /

Country

United States / /

Event

FDA Phase / /

/

IndustryTerm

announcements concerning your device / predicate devices / Internet address http /

MedicalCondition

androgenic alopecia / androgenetic alopecia / VI baldness / /

Organization

Orthopedic And Restorative Devices Office / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / CDRH's office of Surveillance and Biomnetri / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division of Surgical / /

Person

Mark N. Melkerson / /

/

Position

Kit Cariquitan Vice President / Kit Cariquitan Vice President / Regulatory Affairs / physician / Chair / technician / GENERAL INFORMATION Applicant / /

Product

DigiMatch ROBODOC Surgical System / K1 / SECTIONS5 / /

ProgrammingLanguage

NIL / /

ProvinceOrState

California / /

Technology

Design Verification / radiation / http / transplantation / /

URL

www.fdia.pov/AboutFDA/CentersOffics/CDRI-I/CDRHOfices/Lirm / http /

SocialTag