Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K931546 |
Device Name |
END-IRRIGATING ENDOILLUMINATOR |
Applicant |
INFINITECH, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Applicant Contact |
ALAN T BECKMAN |
Correspondent |
INFINITECH, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Correspondent Contact |
ALAN T BECKMAN |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 03/29/1993 |
Decision Date | 02/09/1994 |
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
|