Device Classification Name |
Condom
|
510(k) Number |
K213921 |
Device Name |
Microthin Natural Rubber Latex Condom |
Applicant |
Suretex Limited |
31/1 Moo 4, Suratthani-Thakuapha Road |
Tambon Khao Hua Kwai, Amphur Phunphin,
TH
84130
|
|
Applicant Contact |
KC Nguyen |
Correspondent |
C3-Carey Consultants, LLC |
9451 Ellsworth Court |
Fulton,
MD
20759
|
|
Correspondent Contact |
Carole C. Carey |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/15/2021 |
Decision Date | 04/28/2022 |
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
|
|
|