Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K113697 |
Device Name |
EIGR SURGICAL ILLUMINATION SYSTEM |
Applicant |
INVUITY, INC. |
39 STILLMAN STREET |
SAN FRANCISO,
CA
94107
|
|
Applicant Contact |
THERESA BRANDNER-ALLEN |
Correspondent |
INVUITY, INC. |
39 STILLMAN STREET |
SAN FRANCISO,
CA
94107
|
|
Correspondent Contact |
THERESA BRANDNER-ALLEN |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 12/16/2011 |
Decision Date | 02/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|