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Masks / Food and Drug Administration / Food law / Code of Federal Regulations / Polypropylene / Premarket approval / Medical device / Title 21 of the Code of Federal Regulations / Surgical mask / Medicine / Technology / Medical equipment


510(k) SUMMARY submitted in This summary of 5 10(k) safety and effectiveness information is being accordance with the requirements of SMDA 1990 and 21 CFR §[removed]OCT
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Document Date: 2011-11-28 00:37:42


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File Size: 176,68 KB

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City

Hlauppauge / /

Company

Crosstex International Inc. / SerVICe Crosstex International / Ormsbce Co / /

IndustryTerm

piedicate devices / predicate device / t1w device / polypropylene filter media / /

Organization

FDA / Dental Devices Office / Division of Anesthesiology / DEPARTMENT OF HEALTH / office of Device Evaluation / M.B.A. Director Division / Center for Devices / /

Person

Anesthesiology / Orinsbee / Anthony D. Watson / /

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Position

General / Gary Steinberg President / /

ProgrammingLanguage

Latex / /

ProvinceOrState

New York / /

Technology

radiation / html / /

SocialTag