The following data is part of a premarket notification filed by R.h. Burton Co. with the FDA for Burton Slit Lamp - Model 2000.
Device ID | K924782 |
510k Number | K924782 |
Device Name: | BURTON SLIT LAMP - MODEL 2000 |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City, OH 43123 |
Contact | Kevin M Loychik |
Correspondent | Kevin M Loychik R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City, OH 43123 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-23 |
Decision Date | 1993-01-27 |