Device Classification Name |
Knife, Surgical
|
510(k) Number |
K880094 |
Device Name |
VAN-TEC ENDOPYELOTOMY KNIFE |
Applicant |
VAN-TEC, INC. |
P.O. BOX 26 |
SPENCER,
IN
47460
|
|
Applicant Contact |
VANCE, JR. |
Correspondent |
VAN-TEC, INC. |
P.O. BOX 26 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
VANCE, JR. |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 01/12/1988 |
Decision Date | 02/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|