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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name condom
510(k) Number K160644
Device Name Lelo Hex Natural Rubber Latex Condom
4320 Stevens Creek Blvd., Suite 205
San Jose,  CA  95129
Applicant Contact Pavle Sedic
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number884.5300
Classification Product Code
Date Received03/07/2016
Decision Date 06/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No