Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K953959 |
Device Name |
PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES |
Applicant |
MICROSURGICAL TECHNOLOGY, INC. |
P.O. BOX 2679 |
8415 154TH AVENUE NE |
REDMOND,
WA
98052
|
|
Applicant Contact |
ED TERPILOWSKI |
Correspondent |
MICROSURGICAL TECHNOLOGY, INC. |
P.O. BOX 2679 |
8415 154TH AVENUE NE |
REDMOND,
WA
98052
|
|
Correspondent Contact |
ED TERPILOWSKI |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 08/22/1995 |
Decision Date | 11/17/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|