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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 K171730
Device Name FuckWater
Applicant
Non-Friction Products, Inc.
551 Church St.
Toronto,  CA M4Y 2E2
Applicant Contact Marc Barrette
Correspondent
Monroe Medical Device Consulting, LLC
319 Shilling Dr.
Somerset,  NJ  08873
Correspondent Contact James W. Monroe
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/12/2017
Decision Date 09/07/2017
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
Predetermined Change
Control Plan Authorized		 No
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