Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K863145 |
Device Name |
CERVICAL SCRAPERS |
Applicant |
SURGIPATH MEDICAL INDUSTRIES, INC. |
P.O. BOX 769 |
GRAYSLAKE,
IL
60030
|
|
Applicant Contact |
KEN URBAN |
Correspondent |
SURGIPATH MEDICAL INDUSTRIES, INC. |
P.O. BOX 769 |
GRAYSLAKE,
IL
60030
|
|
Correspondent Contact |
KEN URBAN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/15/1986 |
Decision Date | 08/19/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|