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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 /
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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 /
/
/
Position
General /
Gary Steinberg President /
/
ProgrammingLanguage
Latex /
/
ProvinceOrState
New York /
/
Technology
radiation /
html /
/
SocialTag
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