Device Classification Name |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
|
510(k) Number |
K942407 |
Device Name |
AMCON SLIP IN MYDRIATIC SUNGLASSES |
Applicant |
AMCON LABORATORIES, INC. |
19916 SE 19TH ST. |
ISSAQUAH,
WA
98027
|
|
Applicant Contact |
ANDREA R FRIEDMAN |
Correspondent |
AMCON LABORATORIES, INC. |
19916 SE 19TH ST. |
ISSAQUAH,
WA
98027
|
|
Correspondent Contact |
ANDREA R FRIEDMAN |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 05/20/1994 |
Decision Date | 06/06/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|