Device Classification Name |
Ear, Nose, And Throat Stereotaxic Instrument
|
510(k) Number |
K141551 |
Device Name |
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) |
Applicant |
STRYKER CORPORATE |
4100 E. MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
BECKY DITTY |
Correspondent |
STRYKER CORPORATE |
4100 E. MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
BECKY DITTY |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 06/11/2014 |
Decision Date | 09/08/2014 |
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
|
Recalls |
CDRH Recalls
|
|
|