Device Classification Name |
Instrument, Biopsy
|
510(k) Number |
K082681 |
Device Name |
VACORA VACUUM ASSISTED BIOPSY SYSTEM |
Applicant |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -1740
|
|
Applicant Contact |
CINDY MOSS |
Correspondent |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -1740
|
|
Correspondent Contact |
CINDY MOSS |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 09/15/2008 |
Decision Date | 10/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|