Device Classification Name |
specula, ophthalmic
|
510(k) Number |
K964289 |
Device Name |
EYE FIXATION SPECULUM |
Applicant |
EYEFIX, INC. |
12300 TWINBROOK PKWY. |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
RICHARD E LIPPMAN |
Correspondent |
EYEFIX, INC. |
12300 TWINBROOK PKWY. |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
RICHARD E LIPPMAN |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 10/28/1996 |
Decision Date | 12/17/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|