Device Classification Name |
shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
|
510(k) Number |
K840444 |
Device Name |
NEONATE MASK FOR BABIES |
Applicant |
RICHARDS MEDICAL CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
RICHARDS MEDICAL CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 02/01/1984 |
Decision Date | 03/16/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|