The following data is part of a premarket notification filed by Haag-streit Ag with the FDA for Slit Lamp Bo 900, Bq 900, Bp900.
Device ID | K100202 |
510k Number | K100202 |
Device Name: | SLIT LAMP BO 900, BQ 900, BP900 |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | HAAG-STREIT AG GARTENSTADTSTRASSE 10 Koeniz, CH Ch-3098 |
Contact | Oscar Banz |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-01-25 |
Decision Date | 2010-03-19 |
Summary: | summary |