Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K853883 |
Device Name |
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR |
Applicant |
MEDICAL CORP. OF AMERICA |
28481 LAFALDA |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
THOMAS V KEELEY |
Correspondent |
MEDICAL CORP. OF AMERICA |
28481 LAFALDA |
LAGUNA NIGUEL,
CA
92677
|
|
Correspondent Contact |
THOMAS V KEELEY |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 09/19/1985 |
Decision Date | 10/08/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|