Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K090115 |
Device Name |
RETINA CAMERA TRC-NW7SF MARK II |
Applicant |
TOPCON CORP. |
75-1 HASUNUMA-CHO |
ITABASHI-KU |
TOKYO,
JP
174
|
|
Applicant Contact |
TAKAO SUGAWARA |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 01/21/2009 |
Decision Date | 06/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|