Device Classification Name |
Brush, Endometrial
|
510(k) Number |
K881220 |
Device Name |
ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER |
Applicant |
LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES |
23 WELISEWITZ RD. |
RINGOES,
NJ
08551
|
|
Applicant Contact |
RANDOLPH L COOKE |
Correspondent |
LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES |
23 WELISEWITZ RD. |
RINGOES,
NJ
08551
|
|
Correspondent Contact |
RANDOLPH L COOKE |
Regulation Number | 884.1100
|
Classification Product Code |
|
Date Received | 03/22/1988 |
Decision Date | 06/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|