Device Classification Name |
Rongeur, Manual
|
510(k) Number |
K152734 |
Device Name |
Kerrison Rongeurs |
Applicant |
VITALITEC MEDIZINTECHNIK GMBH |
STEIGAECKER 20 |
BALGHEIM (BADEN-WURTTEM BERG),
DE
78582
|
|
Applicant Contact |
LYNETTE HOWARD |
Correspondent |
LYLE HOWARD CORPORATION |
106 EAST 5TH AVENUE |
MOUNT DORA,
FL
32757
|
|
Correspondent Contact |
LYNETTE HOWARD |
Regulation Number | 882.4840
|
Classification Product Code |
|
Date Received | 09/22/2015 |
Decision Date | 06/18/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|