Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K141330 |
Device Name |
ENDO-CORD |
Applicant |
ENROXTECH, INC. |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Applicant Contact |
LEWIS WARD |
Correspondent |
ENROXTECH, INC. |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Correspondent Contact |
LEWIS WARD |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 05/21/2014 |
Decision Date | 12/15/2014 |
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
|
|
|