The following data is part of a premarket notification filed by Kirchner & Wilhelm Gmbh + Co.kg with the FDA for Piccolight E50,piccolight E56,eurolight E10, Eurolight E30, And Eurolight E36.
| Device ID | K070270 |
| 510k Number | K070270 |
| Device Name: | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | KIRCHNER & WILHELM GMBH + CO.KG 55 NORTHERN BLVD, SUITE 200 Great Neck, NY 11021 |
| Contact | Natalya Valerio |
| Correspondent | Natalya Valerio KIRCHNER & WILHELM GMBH + CO.KG 55 NORTHERN BLVD, SUITE 200 Great Neck, NY 11021 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-29 |
| Decision Date | 2007-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04030155000392 | K070270 | 000 |