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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 K152918
Device Name Gun Oil, Pink, Gun Oil H2O, Pink Water
Applicant
EMPOWERED PRODUCTS, INC.
3367 W. OQUENDO RD.
LAS VEGAS,  NV  89118
Applicant Contact MATT CARR
Correspondent
ADVENA USA, LLC
3010 LBJ FRWY., 12TH FLOOR
DALLAS,  TX  75234
Correspondent Contact JUDY BURTON
Regulation Number884.5300
Classification Product Code
NUC  
Date Received10/02/2015
Decision Date 06/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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