Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K933628 |
Device Name |
CYTOLOGY BRUSH |
Applicant |
BIOTEQUE AMERICA, INC. |
340 EAST MAPLE AVE., #204-C |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
DENIS DORSEY |
Correspondent |
BIOTEQUE AMERICA, INC. |
340 EAST MAPLE AVE., #204-C |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
DENIS DORSEY |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/27/1993 |
Decision Date | 03/11/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|