Device Classification Name |
ophthalmoscope, battery-powered
|
510(k) Number |
K944402 |
Device Name |
FOCOMETER |
Applicant |
LACRIMEDICS, INC. |
190 N. ARROWHEAD AVE, STE B |
RIALTO,
CA
92376
|
|
Applicant Contact |
ROBERT S HERRICK II |
Correspondent |
LACRIMEDICS, INC. |
190 N. ARROWHEAD AVE, STE B |
RIALTO,
CA
92376
|
|
Correspondent Contact |
ROBERT S HERRICK II |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 09/12/1994 |
Decision Date | 11/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|