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 |