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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 K162511
Device Name LELO RESPECT HEX Natural Rubber Latex Condom
Applicant
LELO INC.
4320 STEVENS CREEK BLVD., SUITE 205
SAN JOSE,  CA  95129
Applicant Contact PAVLE SEDIC
Correspondent
REGULATORY INSIGHT, INC.
33 GOLDEN EAGLE LANE
LITTLETON,  CO  80127
Correspondent Contact KEVIN WALLS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/08/2016
Decision Date 01/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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