The following data is part of a premarket notification filed by Michael Onufryk with the FDA for Image Deflector.
Device ID | K833669 |
510k Number | K833669 |
Device Name: | IMAGE DEFLECTOR |
Classification | Frame, Trial, Ophthalmic |
Applicant | MICHAEL ONUFRYK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HPA |
CFR Regulation Number | 886.1415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-18 |
Decision Date | 1984-03-27 |