Device Classification Name |
condom
|
510(k) Number |
K160644 |
Device Name |
Lelo 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 | 03/07/2016 |
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
|
|
|