Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K101496 |
Device Name |
CABLECAP MODEL: WLF, STZ, ACM |
Applicant |
SENSORMED |
2450 EJ CHAPMAN DR., SUITE 104 |
KNOXVILLE,
TN
37996
|
|
Applicant Contact |
WILLIAM MILAM |
Correspondent |
SENSORMED |
2450 EJ CHAPMAN DR., SUITE 104 |
KNOXVILLE,
TN
37996
|
|
Correspondent Contact |
WILLIAM MILAM |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 06/01/2010 |
Decision Date | 09/14/2010 |
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
|
|
|