Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K983428 |
Device Name |
SAFETEX CERVICAL SCRAPER (PLASTIC) |
Applicant |
ANDWIN SCIENTIFIC |
6636 VARIEL AVE. |
CANOGA PARK,
CA
91303
|
|
Applicant Contact |
NATALIE SARRAF |
Correspondent |
ANDWIN SCIENTIFIC |
6636 VARIEL AVE. |
CANOGA PARK,
CA
91303
|
|
Correspondent Contact |
NATALIE SARRAF |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/29/1998 |
Decision Date | 11/16/1998 |
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
|
|
|