Device Classification Name |
Condom
|
510(k) Number |
K982380 |
Device Name |
SURE |
Applicant |
PLEASURE LATEX PRODUCTS SDN. BHD. |
LOT 1365, 17TH MILES, JALAN |
SUNGAI SEMBILANG |
JERAM, SELANGOR,
MY
45800
|
|
Applicant Contact |
CHANG AH KAU |
Correspondent |
PLEASURE LATEX PRODUCTS SDN. BHD. |
LOT 1365, 17TH MILES, JALAN |
SUNGAI SEMBILANG |
JERAM, SELANGOR,
MY
45800
|
|
Correspondent Contact |
CHANG AH KAU |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/08/1998 |
Decision Date | 02/26/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|