Device Classification Name |
syringe, piston |
|||
---|---|---|---|---|
510(k) Number | K021071 | |||
Device Name | PCCS GRAFT DELIVERY SYSTEM | |||
Original Applicant |
|
|||
Original Contact | lonnie witham | |||
Regulation Number | 880.5860 | |||
Classification Product Code |
|
|||
Date Received | 04/02/2002 | |||
Decision Date | 07/01/2002 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
General Hospital |
|||
510k Review Panel |
General & Plastic Surgery |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |