Device Classification Name |
Condom
|
510(k) Number |
K193578 |
Device Name |
Non-spermicidal Lubricated Male Latex Condom |
Applicant |
Global Protection Corp. |
12 Channel Street |
Boston,
MA
02210
|
|
Applicant Contact |
Christina Cataldo |
Correspondent |
Global Protection Corp. |
12 Channel Street |
Boston,
MA
02210
|
|
Correspondent Contact |
Christina Cataldo |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/23/2019 |
Decision Date | 08/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|