Device Classification Name |
staple, implantable |
|||
---|---|---|---|---|
510(k) Number | K040109 | |||
Device Name | HEMORRHAGE OCCLUDER PIN | |||
Applicant |
|
|||
Applicant Contact | arnold r leiboff | |||
Correspondent |
|
|||
Correspodent Contact | arnold r leiboff | |||
Regulation Number | 878.4750 | |||
Classification Product Code |
|
|||
Date Received | 01/20/2004 | |||
Decision Date | 03/25/2004 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
General & Plastic Surgery |
|||
510k Review Panel |
General & Plastic Surgery |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |