The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega 2000.
| Device ID | K982826 |
| 510k Number | K982826 |
| Device Name: | MEGA 2000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | John W Smith |
| Correspondent | John W Smith MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-11 |
| Decision Date | 1998-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10614559101490 | K982826 | 000 |
| 10614559100936 | K982826 | 000 |
| 30614559100947 | K982826 | 000 |
| 10614559100943 | K982826 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEGA 2000 73401040 1301152 Dead/Cancelled |
Pharmavite Corporation 1982-10-28 |