The following data is part of a premarket notification filed by World Of Medicine Lemke Gmbh with the FDA for Endoscopic Camera Tc804/c4.
| Device ID | K014158 |
| 510k Number | K014158 |
| Device Name: | ENDOSCOPIC CAMERA TC804/C4 |
| 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 | 2001-12-19 |
| Decision Date | 2002-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554027501 | K014158 | 000 |
| 03596010657503 | K014158 | 000 |
| 03596010657589 | K014158 | 000 |
| 00888867029354 | K014158 | 000 |
| 04056702002978 | K014158 | 000 |
| 04056702003036 | K014158 | 000 |
| 04056702003043 | K014158 | 000 |
| 04056702003050 | K014158 | 000 |
| 04056702003067 | K014158 | 000 |
| 00885554024920 | K014158 | 000 |
| 00885554025880 | K014158 | 000 |
| 00885554025897 | K014158 | 000 |
| 00885554027402 | K014158 | 000 |
| 00885554027426 | K014158 | 000 |
| 00885554027464 | K014158 | 000 |
| 03596010657497 | K014158 | 000 |