Device Classification Name |
cannula, ophthalmic
|
510(k) Number |
K915074 |
Device Name |
IRRIGATOR/ASPIRATOR PROBE |
Applicant |
BIOMEDICAL DYNAMICS, INC. |
12250 NICOLLET AVE. |
BURNSVILLE,
MN
55337
|
|
Applicant Contact |
JOHN MOBERG |
Correspondent |
BIOMEDICAL DYNAMICS, INC. |
12250 NICOLLET AVE. |
BURNSVILLE,
MN
55337
|
|
Correspondent Contact |
JOHN MOBERG |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 11/08/1991 |
Decision Date | 02/05/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|