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Hygiene / Food law / Water treatment / Pharmaceuticals policy / Disinfectant / Premarket approval / Medical device / Federal Food /  Drug /  and Cosmetic Act / Sterilization / Medicine / Health / Food and Drug Administration


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2014-09-23 12:22:36


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City

North Minneapolis / Minneapolis / /

Company

K133724 Medivators Inc. / Hemoclean Disinfectant KRD CO. LTD / United States MEDIVATORS Inc. / Water Purification Systems / K133724 Trade / HD MEDIVATORS Inc. / Cantel Medical / MEDIVATORS INC. / /

Country

United States / /

Event

FDA Phase / /

Facility

General Hospital / New Hampshire Avenue Document Control Center / /

IndustryTerm

subject device / liquid chemical germicide disinfectant solutions / semi-critical devices / announcements concerning your device / predicate device / manufacturing practice requirements / purification systems / marketed predicate devices / manufacturing practice / physical and chemical properties / Internet address http /

Organization

Division of Postmarket Surveillance / Device Evaluation Center for Devices and Radiological Health Enclosure Premarket Notification / National Institute of Health / Food and Drug Administration / office of Device Evaluation / General Hospital / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH’s office of Surveillance / M.S. Director Division of Anesthesiology / /

Person

Kinnari Shah / Silver Spring / Erin I. Keith / /

/

Position

Senior Regulatory Affairs Specialist / /

Product

acetic acid / Minncare / Federal Food / K133724 / Liquid / /

ProvinceOrState

Minnesota / Maryland / /

Technology

radiation / /

URL

http /

SocialTag