Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K982826 |
Device Name |
MEGA 2000 |
Applicant |
MEGADYNE MEDICAL PRODUCTS, INC. |
11506 SOUTH STATE ST. |
DRAPER,
UT
84020
|
|
Applicant Contact |
JOHN W SMITH |
Correspondent |
MEGADYNE MEDICAL PRODUCTS, INC. |
11506 SOUTH STATE ST. |
DRAPER,
UT
84020
|
|
Correspondent Contact |
JOHN W SMITH |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/11/1998 |
Decision Date | 11/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|