Device Classification Name |
Staple, Implantable
|
510(k) Number |
K041201 |
Device Name |
ULTRACLIP II MR |
Applicant |
INRAD |
4375 DONKER COURT S.E. |
KENTWOOD,
MI
49512
|
|
Applicant Contact |
MELISSA LALOMIA |
Correspondent |
INRAD |
4375 DONKER COURT S.E. |
KENTWOOD,
MI
49512
|
|
Correspondent Contact |
MELISSA LALOMIA |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 05/07/2004 |
Decision Date | 06/03/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|