Device Classification Name |
Endoilluminator
|
510(k) Number |
K946136 |
Device Name |
INFINITECH LIGHTED INFUSION CANNULA |
Applicant |
SURGICAL TECHNOLOGIES, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Applicant Contact |
ALAN T BECKMAN |
Correspondent |
SURGICAL TECHNOLOGIES, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Correspondent Contact |
ALAN T BECKMAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/16/1994 |
Decision Date | 10/02/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|