The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Oms Quartz Infusion Contact Lens.
Device ID | K820223 |
510k Number | K820223 |
Device Name: | OMS QUARTZ INFUSION CONTACT LENS |
Classification | Lens, Fundus, Hruby, Diagnostic |
Applicant | OPTICAL MICRO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HJI |
CFR Regulation Number | 886.1395 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-27 |
Decision Date | 1982-02-05 |