Device Classification Name |
Camera, Television, Endoscopic, Without Audio
|
510(k) Number |
K982397 |
Device Name |
VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM |
Applicant |
ANGIOLAZ, INC. |
INDUSTRIAL PARK |
BELLOWS FALLS,
VT
05101 -0556
|
|
Applicant Contact |
JOHN D PLUMADORE |
Correspondent |
ANGIOLAZ, INC. |
INDUSTRIAL PARK |
BELLOWS FALLS,
VT
05101 -0556
|
|
Correspondent Contact |
JOHN D PLUMADORE |
Regulation Number | 878.4160
|
Classification Product Code |
|
Date Received | 07/09/1998 |
Decision Date | 09/10/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|