The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Retina Camera Trc-nw7sf Mark Ii.
| Device ID | K090115 |
| 510k Number | K090115 |
| Device Name: | RETINA CAMERA TRC-NW7SF MARK II |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TOPCON CORP. 75-1 HASUNUMA-CHO ITABASHI-KU Tokyo, JP 174 |
| Contact | Takao Sugawara |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-06-30 |
| Summary: | summary |