The following data is part of a premarket notification filed by Laser Industries Ltd. with the FDA for Lio-714 Opacitymeter.
Device ID | K790526 |
510k Number | K790526 |
Device Name: | LIO-714 OPACITYMETER |
Classification | Lens, Condensing, Diagnostic |
Applicant | LASER INDUSTRIES LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HJL |
CFR Regulation Number | 886.1380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-15 |
Decision Date | 1979-11-16 |