The following data is part of a premarket notification filed by Haag-streit Ag with the FDA for Bc 900 Slit Lamp.
| Device ID | K982057 |
| 510k Number | K982057 |
| Device Name: | BC 900 SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | HAAG-STREIT AG GARDENSTADTSTRASSE 10 Koeniz, Bern, CH Ch-3098 |
| Contact | Juerg H Schnetzer |
| Correspondent | Juerg H Schnetzer HAAG-STREIT AG GARDENSTADTSTRASSE 10 Koeniz, Bern, CH Ch-3098 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-11 |
| Decision Date | 1998-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640132986150 | K982057 | 000 |
| 07640132986129 | K982057 | 000 |