LELO RESPECT HEX Natural Rubber Latex Condom

Condom

LELO INC.

The following data is part of a premarket notification filed by Lelo Inc. with the FDA for Lelo Respect Hex Natural Rubber Latex Condom.

Pre-market Notification Details

Device IDK162511
510k NumberK162511
Device Name:LELO RESPECT HEX Natural Rubber Latex Condom
ClassificationCondom
Applicant LELO INC. 4320 STEVENS CREEK BLVD., SUITE 205 San Jose,  CA  95129
ContactPavle Sedic
CorrespondentKevin Walls
REGULATORY INSIGHT, INC. 33 GOLDEN EAGLE LANE Littleton,  CO  80127
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-08
Decision Date2017-01-13

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