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FDA 510(k) K141718, INTERNAL HYDRATING GEL, by Combe Incorporated

FDA 510(k) K141718, INTERNAL HYDRATING GEL, by Combe Incorporated

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510(K) Number: K141718
Device Name: INTERNAL HYDRATING GEL
Manufacturer: Combe Incorporated
Device Classification Name: lubricant, personal
Regulation Number: 884.5300
Classification Product Code: NUC
Date Received: 06/25/2014
Decision Date: 11/13/2014
Regulation Medical Specialty: Obstetrics/Gynecology
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