Device Classification Name |
light, surgical, fiberoptic
|
510(k) Number |
K113330 |
Device Name |
CABLECAP |
Applicant |
SENSORMED |
2450 EJ CHAPMAN DR., |
KNOXVILLE,
TN
37996
|
|
Applicant Contact |
WILLIAM MILAM |
Correspondent |
SENSORMED |
2450 EJ CHAPMAN DR., |
KNOXVILLE,
TN
37996
|
|
Correspondent Contact |
WILLIAM MILAM |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 11/14/2011 |
Decision Date | 01/12/2012 |
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
|
|
|