Device Classification Name |
Instrument, Biopsy
|
510(k) Number |
K113872 |
FOIA Releasable 510(k) |
K113872
|
Device Name |
THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE |
Applicant |
VIDACARE CORPORATION |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GRACE HOLLAND |
Correspondent |
VIDACARE CORPORATION |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GRACE HOLLAND |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 12/30/2011 |
Decision Date | 03/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|