Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K880968 |
Device Name |
MODEL 2001 PHACOEMULSIFIER ASPIRATOR |
Applicant |
MCGHAN INSTRUMED CORP. |
3597 E. SUPERNAL CIRCLE |
SALT LAKE CITY,
UT
84121
|
|
Applicant Contact |
EDWARD D FORRESTER |
Correspondent |
MCGHAN INSTRUMED CORP. |
3597 E. SUPERNAL CIRCLE |
SALT LAKE CITY,
UT
84121
|
|
Correspondent Contact |
EDWARD D FORRESTER |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 03/08/1988 |
Decision Date | 04/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|