The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Evans Arm And Hand Rest.
Device ID | K760697 |
510k Number | K760697 |
Device Name: | EVANS ARM AND HAND REST |
Classification | Table, Instrument, Manual, Ophthalmic |
Applicant | ALCON LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRK |
CFR Regulation Number | 886.4855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-22 |
Decision Date | 1976-11-02 |