The following data is part of a premarket notification filed by World Of Medicine Lemke Gmbh with the FDA for Endoscopic Light Source, Model Xl300/l5.
| Device ID | K021717 |
| 510k Number | K021717 |
| Device Name: | ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | WORLD OF MEDICINE LEMKE GMBH 91 TROWBRIDGE ST. Cambridge, MA 02138 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab WORLD OF MEDICINE LEMKE GMBH 91 TROWBRIDGE ST. Cambridge, MA 02138 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-23 |
| Decision Date | 2002-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702003234 | K021717 | 000 |