Device Classification Name |
shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
|
510(k) Number |
K934085 |
Device Name |
MODIFICATION OF SURGICAL EYESHIELD MASK |
Applicant |
AMERICAN THRESHOLD INDUSTRIES, INC. |
240 SARDIS RD. |
P.O. BOX 1209 |
ENKA,
NC
28728
|
|
Applicant Contact |
ROBERT T BAYER |
Correspondent |
AMERICAN THRESHOLD INDUSTRIES, INC. |
240 SARDIS RD. |
P.O. BOX 1209 |
ENKA,
NC
28728
|
|
Correspondent Contact |
ROBERT T BAYER |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 08/20/1993 |
Decision Date | 11/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|