Device Classification Name |
condom
|
510(k) Number |
K211152 |
Device Name |
Durex Condom with Benzocaine |
Applicant |
RB Health (US) LLC |
399 Interpace Parkway |
Parsippany,
NJ
07054
|
|
Applicant Contact |
Kyle Prince |
Correspondent |
RB Health (US) LLC |
399 Interpace Parkway |
Parsippany,
NJ
07054
|
|
Correspondent Contact |
Kyle Prince |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/19/2021 |
Decision Date | 05/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|