Device Classification Name |
condom
|
510(k) Number |
K181844 |
Device Name |
One Touch |
Applicant |
Thai Nippon Rubber Industry Public Company Ltd |
1 Charoenrat Road, Thungwatdon, Sathon |
bangkok,
TH
10120
|
|
Applicant Contact |
pisut chanwatarungkull |
Correspondent |
KUPS International |
8516 Burning Tree Road, |
bethesda,
MD
20817
|
|
Correspondent Contact |
prabhat garg |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/11/2018 |
Decision Date | 04/15/2019 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
summary |
summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|