Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K021077 |
Device Name |
MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD |
Applicant |
MEGADYNE MEDICAL PRODUCTS, INC. |
11506 SOUTH STATE ST. |
DRAPER,
UT
84020
|
|
Applicant Contact |
RONDA K MAGNESON |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/03/2002 |
Decision Date | 04/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|