Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K954562 |
Device Name |
GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT |
Applicant |
GYNETECH, INC. |
P. O. BOX 101 |
SPRINGDALE,
AR
72765
|
|
Applicant Contact |
WILLIAM J DUNN |
Correspondent |
GYNETECH, INC. |
P. O. BOX 101 |
SPRINGDALE,
AR
72765
|
|
Correspondent Contact |
WILLIAM J DUNN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 10/02/1995 |
Decision Date | 12/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|