Device Classification Name |
Endoscope, Flexible
|
510(k) Number |
K860771 |
Device Name |
VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE |
Applicant |
VAN-TEC, INC. |
P.O. BOX 26 |
SPENCER,
IN
47460
|
|
Applicant Contact |
JAMES F VANCE |
Correspondent |
VAN-TEC, INC. |
P.O. BOX 26 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
JAMES F VANCE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/03/1986 |
Decision Date | 04/23/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|