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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 K111093
Device Name BILLY BOY MALE LATEX CONDOM
Applicant
MAPA GMBH
INDUSTRIESTRASSE 21-25
zeven,  DE 27404
Applicant Contact german frank
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact mark job
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/19/2011
Decision Date 06/03/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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