Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K123365 |
Device Name |
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY |
P.O. BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY |
P.O. BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 884.1720
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/31/2012 |
Decision Date | 03/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|