The following data is part of a premarket notification filed by R.h. Burton Co. with the FDA for Trial Lens Set.
Device ID | K920571 |
510k Number | K920571 |
Device Name: | TRIAL LENS SET |
Classification | Set, Lens, Trial, Ophthalmic |
Applicant | R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City, OH 43123 |
Contact | Tammy Dern |
Correspondent | Tammy Dern R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City, OH 43123 |
Product Code | HPC |
CFR Regulation Number | 886.1405 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-07 |
Decision Date | 1992-05-07 |