Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K082834 |
Device Name |
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC |
Applicant |
ELLMAN INT'L INC. |
3333 ROYAL AVENUE |
OCEANSIDE,
NY
11572 -3625
|
|
Applicant Contact |
RICK EPSTEIN |
Correspondent |
ELLMAN INT'L INC. |
3333 ROYAL AVENUE |
OCEANSIDE,
NY
11572 -3625
|
|
Correspondent Contact |
RICK EPSTEIN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/26/2008 |
Decision Date | 05/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|