Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K053382 |
Device Name |
LAPARO-THORACO VIDEOSCOPE XLTF-VAW |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
TRACY GULSEN |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
TRACY GULSEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/05/2005 |
Decision Date | 05/26/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|