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Food and Drug Administration / Fertility medicine / HIV/AIDS / Sexual health / Personal lubricant / Condom / Female condom / Premarket approval / Federal Food / Drug / and Cosmetic Act / Medicine / Health / Medical technology


- 51 0(k) Premarket Notification CONCEIVE PLUS® 510(K) SUMMARY
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Document Date: 2013-12-09 11:45:24

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File Size: 193,39 KB

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City

Brussels / Chicago / /

Company

K131355 Trade / Sasmar Inc. / K131355 SUBMITTER SASMAR INC. / /

Event

FDA Phase / /

/

IndustryTerm

manufacturing / rubber / /

Organization

FDA / European Union / DEPARTMENT OF HEALTH / /

Person

Benjamin R. Fisher / John-Michael Mancini / Cosmetic Act (Act) / /

/

Position

Major / Director / Chief Executive Officer / /

Product

Potassium Chloride / Sodium Chloride / Calcium Chloride / sterile water / K13 / /

ProvinceOrState

Illinois / /

Technology

radiation / http / /

URL

www.fdaizov/AboutFDA/Centersffices/CDRH/CD.HOffices/icm / http /

SocialTag