Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K912882 |
Device Name |
INNERVISION LAPAROSCOPE AND ACCESSORIES |
Applicant |
M.D. ENGINEERING, INC. |
2536 BARRINGTON COURT |
HAYWARD,
CA
94545
|
|
Applicant Contact |
ANDREW HALSEY |
Correspondent |
M.D. ENGINEERING, INC. |
2536 BARRINGTON COURT |
HAYWARD,
CA
94545
|
|
Correspondent Contact |
ANDREW HALSEY |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 07/01/1991 |
Decision Date | 01/24/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|