The following data is part of a premarket notification filed by Modern Medical Equipment Manufacturing Limited with the FDA for Disposable Laparoscopic Electrode, Disposable Laparoscopic Electrode.
| Device ID | K134006 |
| 510k Number | K134006 |
| Device Name: | DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED 35-41 TAI LIN PAI ROAD, 5F GOLD KING INDUSTRIAL BUILDING KWAI CHUNG Hong Kong, CN Ch |
| Contact | Thomas Chan Tsz Fung |
| Correspondent | Thomas Chan Tsz Fung MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED 35-41 TAI LIN PAI ROAD, 5F GOLD KING INDUSTRIAL BUILDING KWAI CHUNG Hong Kong, CN Ch |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-27 |
| Decision Date | 2014-11-21 |
| Summary: | summary |