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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 K103119
Device Name BILLY BOY MALE LATEX CONDOM
Applicant
SHEILA PICKERING PH.D.
2061 LONGDEN CIRCLE
LOS ALTOS,  CA  94024
Applicant Contact SHEILA W PICKERING
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 Received10/22/2010
Decision Date 02/24/2011
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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