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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 K141718
FOIA Releasable 510(k) K141718
Device Name INTERNAL HYDRATING GEL
Applicant
COMBE INCORPORATED
1101 WESTCHESTER AVE.
WHITE PLAINS,  NY  10604
Applicant Contact PUSHPA RAO
Correspondent
COMBE INCORPORATED
1101 WESTCHESTER AVE.
WHITE PLAINS,  NY  10604
Correspondent Contact PUSHPA RAO
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/25/2014
Decision Date 11/13/2014
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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