Device Classification Name |
guide, surgical, instrument
|
510(k) Number |
K871413 |
Device Name |
CIVCO STEPPER |
Applicant |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
418 B AVE. |
KALONA,
IA
52247
|
|
Applicant Contact |
VICTOR J WEDEL |
Correspondent |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
418 B AVE. |
KALONA,
IA
52247
|
|
Correspondent Contact |
VICTOR J WEDEL |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 04/08/1987 |
Decision Date | 07/14/1987 |
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
|
|
|