Device Classification Name |
cannula, ophthalmic
|
510(k) Number |
K860744 |
Device Name |
OPTHALMIC SURGICAL INSTRUMENTS |
Applicant |
TRIDAK DIVISION OF INDICON, INC. |
ONE BLUE HILL PLAZA |
SUITE 815 |
PEARL RIVER,
NY
10965
|
|
Applicant Contact |
CORINNE M AMBROSINO |
Correspondent |
TRIDAK DIVISION OF INDICON, INC. |
ONE BLUE HILL PLAZA |
SUITE 815 |
PEARL RIVER,
NY
10965
|
|
Correspondent Contact |
CORINNE M AMBROSINO |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 02/27/1986 |
Decision Date | 03/31/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|