Device Classification Name |
syringe, piston
|
510(k) Number |
K041976 |
Device Name |
SMITH & NEPHEW GRAFT DELIVERY SYSTEM |
Applicant |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
KIM P KELLY |
Correspondent |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
KIM P KELLY |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 07/22/2004 |
Decision Date | 08/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|