Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K941950 |
Device Name |
OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360 |
Applicant |
BAXTER HEALTHCARE CORP. |
1435 LAKE COOK RD. |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
NICOLE M CLARK |
Correspondent |
BAXTER HEALTHCARE CORP. |
1435 LAKE COOK RD. |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
NICOLE M CLARK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/21/1994 |
Decision Date | 08/11/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|