Device Classification Name |
Chart, Visual Acuity
|
510(k) Number |
K944156 |
Device Name |
HEINE LAMBDA 100 |
Applicant |
HEINE USA, LTD. |
3500 REGENCY PARKWAY SUITE"C" |
CARY,
NC
27511 -8569
|
|
Applicant Contact |
BEN S JEAN |
Correspondent |
HEINE USA, LTD. |
3500 REGENCY PARKWAY SUITE"C" |
CARY,
NC
27511 -8569
|
|
Correspondent Contact |
BEN S JEAN |
Regulation Number | 886.1150
|
Classification Product Code |
|
Date Received | 08/26/1994 |
Decision Date | 01/12/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|