The following data is part of a premarket notification filed by Expertech Assoc., Inc. with the FDA for Rodenstock Slitlamp (model 5000 & 4000).
| Device ID | K962532 |
| 510k Number | K962532 |
| Device Name: | RODENSTOCK SLITLAMP (MODEL 5000 & 4000) |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | EXPERTECH ASSOC., INC. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | David M Link |
| Correspondent | David M Link EXPERTECH ASSOC., INC. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1996-07-25 |
| Summary: | summary |