Device Classification Name |
Retractor, Self-Retaining, For Neurosurgery
|
510(k) Number |
K161004 |
Device Name |
Self-retaining Retractor |
Applicant |
FETZER MEDICAL GMBH & CO.KG |
UNTER BUCHSTEIG 5 |
Tuttlingen,
DE
78532
|
|
Applicant Contact |
Harald Jung |
Correspondent |
FETZER MEDICAL GMBH & CO.KG |
UNTER BUCHSTEIG 5 |
Tuttlingen,
DE
78532
|
|
Correspondent Contact |
Harald Jung |
Regulation Number | 882.4800
|
Classification Product Code |
|
Date Received | 04/11/2016 |
Decision Date | 09/09/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|