Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K921294 |
Device Name |
VIDEO ENDOSCOPE-RIGID MODIFICATION |
Applicant |
MEDICAL DYNAMICS, INC. |
99 INVERNESS DR., EAST |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
JO BREHM |
Correspondent |
MEDICAL DYNAMICS, INC. |
99 INVERNESS DR., EAST |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
JO BREHM |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 03/17/1992 |
Decision Date | 07/20/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|