Device Classification Name |
Marker, Radiographic, Implantable
|
510(k) Number |
K090547 |
Device Name |
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U |
Applicant |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -2438
|
|
Applicant Contact |
CINDY MOSS |
Correspondent |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -2438
|
|
Correspondent Contact |
CINDY MOSS |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 03/02/2009 |
Decision Date | 03/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|