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 Number | 884.5300
|
Classification Product Code |
|
Date Received | 09/08/2016 |
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
|
|
|