Device Classification Name |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
|
510(k) Number |
K872659 |
Device Name |
TAPELESS EYE SHIELD |
Applicant |
PRECISION THERAPEUTICS, INC. |
2927 SOUTH INDUSTRIAL RD. |
LAS VEGAS,
NV
89109
|
|
Applicant Contact |
LEONARDI, M.D. |
Correspondent |
PRECISION THERAPEUTICS, INC. |
2927 SOUTH INDUSTRIAL RD. |
LAS VEGAS,
NV
89109
|
|
Correspondent Contact |
LEONARDI, M.D. |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 07/07/1987 |
Decision Date | 07/27/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|