The following data is part of a premarket notification filed by Cso with the FDA for Sl990, Sl980, Sl950.
Device ID | K992836 |
510k Number | K992836 |
Device Name: | SL990, SL980, SL950 |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | CSO 197 BELVOIR RD. Williamsville, NY 14221 |
Contact | R. Brent Miner |
Correspondent | R. Brent Miner CSO 197 BELVOIR RD. Williamsville, NY 14221 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-23 |
Decision Date | 1999-11-09 |
Summary: | summary |