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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 K171855
Device Name External Moisturizing Gel
Applicant
Combe Incorporated
1101 Westchester Ave.
White Plains,  NY  10604
Applicant Contact Richard Grabarz
Correspondent
Combe Incorporated
1101 Westchester Ave.
White Plains,  NY  10604
Correspondent Contact Richard Grabarz
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/21/2017
Decision Date 07/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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