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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 K124044
FOIA Releasable 510(k) K124044
Device Name ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
Applicant
SEVEN OAKS RANCH, INC.
2658 CHANNEL DRIVE
VENTURA,  CA  93003
Applicant Contact Calley Herzog
Correspondent
SEVEN OAKS RANCH, INC.
2658 CHANNEL DRIVE
VENTURA,  CA  93003
Correspondent Contact Calley Herzog
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/31/2012
Decision Date 08/30/2013
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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