Device Classification Name |
esophagoscope (flexible or rigid)
|
510(k) Number |
K142695 |
Device Name |
Cytosponge Cell Collection Device |
Applicant |
Covidien LLC |
15 HAMPSHIRE ST |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
Richelle Hover |
Correspondent |
Covidien LLC |
15 HAMPSHIRE ST |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
Richelle Hover |
Regulation Number | 874.4710
|
Classification Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 11/26/2014 |
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
|
|
|