The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Haag-streit Slit Lamp 900.
Device ID | K792083 |
510k Number | K792083 |
Device Name: | HAAG-STREIT SLIT LAMP 900 |
Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
Applicant | LUMENIS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRM |
CFR Regulation Number | 878.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-16 |
Decision Date | 1979-11-16 |