Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K091074 |
Device Name |
AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES |
Applicant |
ENCISION, INC. |
6797 WINCHESTER CIR. |
BOULDER,
CO
80301
|
|
Applicant Contact |
JUDITH KING |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAY KOGOMA |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/14/2009 |
Decision Date | 08/17/2009 |
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
|