Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K081522 |
Device Name |
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY |
Applicant |
BIO NUCLEAR DIAGNOSTICS, INC. |
1791 ALBION RD. |
TORONTO, ONTARIO,
CA
M9W 5S7
|
|
Applicant Contact |
SURENDER CHOUDHRY |
Correspondent |
BIO NUCLEAR DIAGNOSTICS, INC. |
1791 ALBION RD. |
TORONTO, ONTARIO,
CA
M9W 5S7
|
|
Correspondent Contact |
SURENDER CHOUDHRY |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/30/2008 |
Decision Date | 12/05/2008 |
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
|
|
|