Device Classification Name |
brush, biopsy, bronchoscope (non-rigid)
|
510(k) Number |
K130357 |
FOIA Releasable 510(k) |
K130357
|
Device Name |
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH |
Applicant |
Covidien LLC |
161 CHESHIRE LANE STE 100 |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
KRISTEN SWANSON |
Correspondent |
Covidien LLC |
161 CHESHIRE LANE STE 100 |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
KRISTEN SWANSON |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 02/13/2013 |
Decision Date | 11/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|