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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, personal
510(k) Number K130345
Device Name AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
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
NUC  
Date Received02/11/2013
Decision Date 08/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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