Device Classification Name |
Pump, Infusion
|
510(k) Number |
K122215 |
Device Name |
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
Applicant |
CARTICEPT MEDICAL, INC. |
6120 Windward Pkwy Ste 220 |
Alpharetta,
GA
30005
|
|
Applicant Contact |
Tanya Eberle |
Correspondent |
CARTICEPT MEDICAL, INC. |
6120 Windward Pkwy Ste 220 |
Alpharetta,
GA
30005
|
|
Correspondent Contact |
Tanya Eberle |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 10/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|