Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K936304 |
Device Name |
ELECTROSURGICAL PENCIL |
Applicant |
E & M ENGINEERING, INC. |
2116 DABNEY RD. |
SUITE A-5 |
RICHMOND,
VA
23230
|
|
Applicant Contact |
WINNY CHOW |
Correspondent |
E & M ENGINEERING, INC. |
2116 DABNEY RD. |
SUITE A-5 |
RICHMOND,
VA
23230
|
|
Correspondent Contact |
WINNY CHOW |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/20/1993 |
Decision Date | 06/13/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|