Device Classification Name |
Condom
|
510(k) Number |
K893039 |
Device Name |
CONDOM (RUBBER) CONTRACEPTIVE |
Applicant |
CHINTEIK HYGIENE PRODUCTS CO.,LTD. |
60/50 NAVANAKORN IND. ESTATE |
ZONE 2, PHAHOLYOTHIN RD. |
PATHUMTHANI,
TH
12120
|
|
Applicant Contact |
NGANTHAWE |
Correspondent |
CHINTEIK HYGIENE PRODUCTS CO.,LTD. |
60/50 NAVANAKORN IND. ESTATE |
ZONE 2, PHAHOLYOTHIN RD. |
PATHUMTHANI,
TH
12120
|
|
Correspondent Contact |
NGANTHAWE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/24/1989 |
Decision Date | 05/04/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|