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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 St., Suite 101
Berkely,  CA  94704
Applicant Contact DAVID P MAYER
Correspondent
Mayer Laboratories, Inc.
1950 Addison St., Suite 101
Berkely,  CA  94704
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
Predetermined Change
Control Plan Authorized		 No
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