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Human reproduction / Feminine hygiene / Food law / Personal hygiene products / Tampon / Rely / Medical device / Playtex / Premarket approval / Medicine / Health / Food and Drug Administration


Document Date: 2012-03-26 00:30:36

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City

Commerce DriveAllendale / Shelton / ALLENDALE NJ / DriveAllendale / /

Company

Research & Development Playtex Products LLC / Playtex Products LLC / Manager Product Safety/Regulatory Affairs Playtex Manufacturing Inc. / K1 11684 Trade / /

Event

FDA Phase / /

IndustryTerm

announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / odor absorbing technology / Internet address http /

MedicalCondition

ISensitization - Human Repeat Insult Patch Test Irritation / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Division of Reproductive / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Reproductive / Gastro-Renal / and Urological Devices Office / /

Person

R. Fisher / Silver Spring / Pushpa Rao / /

/

Position

Manager / Product Safety/Regulatory Affairs / /

Product

Federal Food / /

ProvinceOrState

New Jersey / Maryland / Connecticut / /

Technology

radiation / OdorShieldTM technology / Teacologicl Charateriticsthe odor absorbing technology / /

URL

http /

SocialTag