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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 K161585
Device Name Mano and Mano Personal Lubricant
Applicant
Mano and Mano Proprietary Limited
286 Chesterville Rd.
Moorabbin,  AU 3189
Applicant Contact Katrina Allen
Correspondent
Clinreg Consulting Services, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact Gary Mocnik
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/08/2016
Decision Date 09/06/2016
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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