Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K963801 |
Device Name |
PAP BRUSH |
Applicant |
YOUNG OU BRUSH CO. |
966-114 KANG KEUN-DONG |
OKPO-MEUN, DALSUN-KUN |
KYONG BUK,
KR
|
|
Applicant Contact |
STEVE KWAK |
Correspondent |
YOUNG OU BRUSH CO. |
966-114 KANG KEUN-DONG |
OKPO-MEUN, DALSUN-KUN |
KYONG BUK,
KR
|
|
Correspondent Contact |
STEVE KWAK |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/23/1996 |
Decision Date | 04/09/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|