Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K955635 |
Device Name |
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND |
Applicant |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Applicant Contact |
LAWRENCE E MAROCCO |
Correspondent |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent Contact |
LAWRENCE E MAROCCO |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 12/11/1995 |
Decision Date | 05/07/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|