Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K984276 |
Device Name |
DISPOSABLE ELECTROSURGERY GROUNDING PAD |
Applicant |
E & M ENGINEERING, INC. |
1705 DABNEY RD. |
RICHMOND,
VA
23230
|
|
Applicant Contact |
ROGER STRUBE |
Correspondent |
E & M ENGINEERING, INC. |
1705 DABNEY RD. |
RICHMOND,
VA
23230
|
|
Correspondent Contact |
ROGER STRUBE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/30/1998 |
Decision Date | 02/10/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|