Device Classification Name |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
|
510(k) Number |
K940095 |
Device Name |
FOX EYE ALUMINUM SHIELD, OPHTHALMIC |
Applicant |
P.J. PRODUCTS, INC. |
8535 WEST BELLFORT |
HOUSTON,
TX
77071
|
|
Applicant Contact |
JOEL H GOFFMAN, M.D. |
Correspondent |
P.J. PRODUCTS, INC. |
8535 WEST BELLFORT |
HOUSTON,
TX
77071
|
|
Correspondent Contact |
JOEL H GOFFMAN, M.D. |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 01/07/1994 |
Decision Date | 03/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|