The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Meditron Combination Generator Cg-2000.
| Device ID | K912182 |
| 510k Number | K912182 |
| Device Name: | MEDITRON COMBINATION GENERATOR CG-2000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-16 |
| Decision Date | 1991-09-06 |