Device Classification Name |
instrument, vitreous aspiration and cutting, ac-powered
|
510(k) Number |
K853382 |
Device Name |
MAID MENTOR ASPIRATION/IRRIGATION DEVRO |
Applicant |
MENTOR O & O, INC. |
SOUTH SHORE PARK |
HINGHAM,
MA
02043
|
|
Applicant Contact |
DAVID M LINK |
Correspondent |
MENTOR O & O, INC. |
SOUTH SHORE PARK |
HINGHAM,
MA
02043
|
|
Correspondent Contact |
DAVID M LINK |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 08/12/1985 |
Decision Date | 10/04/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|