Device Classification Name |
Microdebrider, Ent, High Speed, Single Use, Reprocessed
|
510(k) Number |
K142022 |
Device Name |
MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES |
Applicant |
MEDLINE RENEWAL |
2747 SW 6th St |
REDMOND,
OR
97756
|
|
Applicant Contact |
RICHARD D WYNKOOP |
Correspondent |
MEDLINE RENEWAL |
2747 SW 6th St |
REDMOND,
OR
97756
|
|
Correspondent Contact |
RICHARD D WYNKOOP |
Regulation Number | 874.4140
|
Classification Product Code |
|
Date Received | 07/25/2014 |
Decision Date | 12/19/2014 |
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
|
|
|