Device Classification Name |
condom
|
510(k) Number |
K171213 |
Device Name |
One Touch Condom with Benzocaine |
Applicant |
Thai Nippon Rubber Industry Public Company Limited |
1 Charoenrat Road, Thungwatdon, Sathon |
Bangkok,
TH
10120
|
|
Applicant Contact |
Pisut Chanwatarungkull (Pete) |
Correspondent |
Thai Nippon Rubber Industry Public Company Limited |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/25/2017 |
Decision Date | 01/12/2018 |
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 |
Yes
|
|
|