The following data is part of a premarket notification filed by World Of Medicine Lemke Gmbh with the FDA for Endoscopic Camera Mc404/c3.
| Device ID | K020336 |
| 510k Number | K020336 |
| Device Name: | ENDOSCOPIC CAMERA MC404/C3 |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-01 |
| Decision Date | 2002-03-14 |
| Summary: | summary |