Device Classification Name |
implant, eye sphere
|
510(k) Number |
K862977 |
Device Name |
MEDITRADE ARTIFICIAL EYES AND IMPLANTS |
Applicant |
MEDITRADE, INC. |
ALLEN E. SMITH AND ASSOCIATES |
1111 MCALLEN STATE BANK TOWER |
MCALLEN,
TX
78501
|
|
Applicant Contact |
NOLAN K STUTZMAN |
Correspondent |
MEDITRADE, INC. |
ALLEN E. SMITH AND ASSOCIATES |
1111 MCALLEN STATE BANK TOWER |
MCALLEN,
TX
78501
|
|
Correspondent Contact |
NOLAN K STUTZMAN |
Regulation Number | 886.3320
|
Classification Product Code |
|
Date Received | 08/07/1986 |
Decision Date | 10/20/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|