The following data is part of a premarket notification filed by Keeler Optical Products Ltd. with the FDA for Nevyas Autopress Eye Compressor.
Device ID | K792255 |
510k Number | K792255 |
Device Name: | NEVYAS AUTOPRESS EYE COMPRESSOR |
Classification | Applicator, Ocular Pressure |
Applicant | KEELER OPTICAL PRODUCTS LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LCC |
CFR Regulation Number | 886.4610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-09 |
Decision Date | 1979-12-11 |