The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Slit Lamp Sl-d701.
Device ID | K133667 |
510k Number | K133667 |
Device Name: | SLIT LAMP SL-D701 |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | TOPCON CORP. 5 TIMBER LANE North Reading, MA 01864 |
Contact | Maureen O'connell |
Correspondent | Maureen O'connell TOPCON CORP. 5 TIMBER LANE North Reading, MA 01864 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-29 |
Decision Date | 2014-08-26 |
Summary: | summary |