The following data is part of a premarket notification filed by F. & F. Koenigkramer with the FDA for Reliance Ophthalmic Instrument Control.
Device ID | K812544 |
510k Number | K812544 |
Device Name: | RELIANCE OPHTHALMIC INSTRUMENT CONTROL |
Classification | Stand, Instrument, Ac-powered, Ophthalmic |
Applicant | F. & F. KOENIGKRAMER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HMF |
CFR Regulation Number | 886.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-04 |
Decision Date | 1981-09-21 |