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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name condom
510(k) Number K011378
Device Name JOE LUB HELMET CONDOM
Applicant
MARKETING SALES CONCEPTS, INC. (MSCI)
200 RENAISSANCE COMPANY
SUITE 111
atlanta,  GA  30308
Applicant Contact eric j arthur
Correspondent
MARKETING SALES CONCEPTS, INC. (MSCI)
200 RENAISSANCE COMPANY
SUITE 111
atlanta,  GA  30308
Correspondent Contact eric j arthur
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/03/2001
Decision Date 03/25/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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