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Health / Food law / Clinical research / Pharmaceutical industry / Medical device / Medical equipment / Perfusion / Title 21 of the Code of Federal Regulations / Indocyanine green / Medicine / Food and Drug Administration / Technology


MAY[removed]Traditional 51 0(k) Fluoptics K132475
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Document Date: 2014-06-06 11:51:54

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File Size: 158,80 KB

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City

Hamamatsu City / Snowberry Court Orinda / Court Orinda / /

Company

K132475 Trade / A. Daniel Daniel & Daniel Consulting LLC / /

Continent

Europe / /

Currency

USD / /

Event

FDA Phase / /

Facility

Court Orinda / /

IndustryTerm

announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / cited predicate device / laser product / Internet address htto /

MedicalTreatment

organ transplant surgeries / surgeries / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / F.A.C.S. Acting Director Division / FDA / New Haompshire Avenue Document Contro Center / Surgical Devices Office / DEPARTMENT OF HEALTH / Device Evaluation Center for Devices and Radiological Health Enclosure / Camera Unit / CDRH's office of Surveillance / Center for Devices / /

Person

Michael A Daniel / Binita S.Ashar / Neil R Ogden / Michael A. Daniel / /

/

Position

Consultant / Controller / /

Product

Indocyanine green / Federal Food / /

ProgrammingLanguage

V / /

ProvinceOrState

Maryland / California / /

Technology

radiation / laser / X-Ray System / /

URL

www.fda.gov/MedicalDevices/Safev/ReportaProblem/fdefault~htm / www.fda.gov/MedicalDevices/ResourcesforYou/industrv/default.htm / http /

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