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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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