Device Classification Name |
condom
|
510(k) Number |
K132390 |
Device Name |
INSTINCT; PLAIN, DOTTED, ULTRA THIN |
Applicant |
PROFILATEX, S.A. DE C.V. |
FEBRERO DE 1917 #4 |
COL. CIPRESES |
CHALCO,
MX
56600
|
|
Applicant Contact |
JUAN ERNESTO DE LA PUENTE |
Correspondent |
PROFILATEX, S.A. DE C.V. |
FEBRERO DE 1917 #4 |
COL. CIPRESES |
CHALCO,
MX
56600
|
|
Correspondent Contact |
JUAN ERNESTO DE LA PUENTE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/01/2013 |
Decision Date | 04/22/2014 |
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
|
|
|