Device Classification Name |
Magnet, Permanent
|
510(k) Number |
K880855 |
Device Name |
PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG |
Applicant |
RICHARD JAMES, INC. |
P.O. BOX 309 |
LYNNFIELD,
MA
01940
|
|
Applicant Contact |
WAYNE A RICHARD |
Correspondent |
RICHARD JAMES, INC. |
P.O. BOX 309 |
LYNNFIELD,
MA
01940
|
|
Correspondent Contact |
WAYNE A RICHARD |
Regulation Number | 886.4445
|
Classification Product Code |
|
Date Received | 03/01/1988 |
Decision Date | 04/01/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|