Device Classification Name |
Retractor
|
510(k) Number |
K071775 |
Device Name |
DASH |
Applicant |
EZSURGICAL |
13 RED FOX LANE |
LITTLETON,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
EZSURGICAL |
13 RED FOX LANE |
LITTLETON,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 06/29/2007 |
Decision Date | 08/07/2007 |
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
|
|
|