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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 K113686
Device Name KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
Applicant
MAYER LABORATORIES, INC.
1950 ADDISON STREET, SUITE 101
berkely,  CA  94704 -1182
Applicant Contact david p mayer
Correspondent
MAYER LABORATORIES, INC.
1950 ADDISON STREET, SUITE 101
berkely,  CA  94704 -1182
Correspondent Contact david p mayer
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/15/2011
Decision Date 03/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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