Device Classification Name |
spectacle, magnifying
|
510(k) Number |
K844716 |
Device Name |
MAGNIFYING SPECTACLES W/PLASTIC LENSES |
Applicant |
GAZELLE CORP. |
72-9 JEN AI RD., SEC. 2 |
TAIPEI,
TW
|
|
Applicant Contact |
PAUL HUANG |
Correspondent |
GAZELLE CORP. |
72-9 JEN AI RD., SEC. 2 |
TAIPEI,
TW
|
|
Correspondent Contact |
PAUL HUANG |
Regulation Number | 886.5840
|
Classification Product Code |
|
Date Received | 12/04/1984 |
Decision Date | 01/03/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|