Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K853389 |
Device Name |
WALLACH ZOOM COLPOSCOPE |
Applicant |
WALLACH SURGICAL DEVICES, INC. |
273 LINWOOD AVE. |
FAIRFIELD,
CT
06430
|
|
Applicant Contact |
RONALD RZASA |
Correspondent |
WALLACH SURGICAL DEVICES, INC. |
273 LINWOOD AVE. |
FAIRFIELD,
CT
06430
|
|
Correspondent Contact |
RONALD RZASA |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 08/13/1985 |
Decision Date | 11/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|