Device Classification Name |
Ear, Nose, And Throat Stereotaxic Instrument
|
510(k) Number |
K133665 |
Device Name |
MALLEABLE SUCTION INSTRUMENTS |
Applicant |
MEDTRONIC NAVIGATION, INC. |
826 COAL CREEK CIR. |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
CHARLES M COPPERBERG |
Correspondent |
MEDTRONIC NAVIGATION, INC. |
826 COAL CREEK CIR. |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
CHARLES M COPPERBERG |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 11/29/2013 |
Decision Date | 03/13/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|