The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Disposable Laparoscopic Instrument.
| Device ID | K070812 |
| 510k Number | K070812 |
| Device Name: | DISPOSABLE LAPAROSCOPIC INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY ROAD Richmond, VA 23230 |
| Contact | Robert Stillman |
| Correspondent | Robert Stillman MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY ROAD Richmond, VA 23230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-09-14 |