K792083 is an FDA 510(k) clearance for the HAAG-STREIT SLIT LAMP 900. This device is classified as a Microscope, Operating & Accessories, Ac-powered, Ophthalmic (Class I - General Controls, product code HRM).
Submitted by Lumenis, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1979, 31 days after receiving the submission on October 16, 1979.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4700.
| 510(k) Number | K792083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1979 |
| Decision Date | November 16, 1979 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | HRM - Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4700 |