Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K902995 |
Device Name |
PC-BEADS POSTCOITAL TEST |
Applicant |
MICROSCOPY RESEARCH INNOVATIONS |
4203 TOWANDA TRAIL |
KNOXVILLE,
TN
37919
|
|
Applicant Contact |
DOODY, MD |
Correspondent |
MICROSCOPY RESEARCH INNOVATIONS |
4203 TOWANDA TRAIL |
KNOXVILLE,
TN
37919
|
|
Correspondent Contact |
DOODY, MD |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/09/1990 |
Decision Date | 01/31/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|