Device Classification Name |
Illuminator, Fiberoptic, Surgical Field
|
510(k) Number |
K890398 |
Device Name |
RYAN-STYLE DIRECTED INFUSION MANIPULATOR |
Applicant |
ADVANCED SURGICAL PRODUCTS, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Applicant Contact |
TODD J HESSEL |
Correspondent |
ADVANCED SURGICAL PRODUCTS, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Correspondent Contact |
TODD J HESSEL |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 01/24/1989 |
Decision Date | 02/17/1989 |
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
|