Device Classification Name |
pump, infusion
|
510(k) Number |
K101194 |
Device Name |
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 |
Applicant |
CARTICEPT MEDICAL INC |
6120 Windward Parkway |
Suite 220 |
Alpharetta,
GA
30005
|
|
Applicant Contact |
Tanya Eberle |
Correspondent |
CARTICEPT MEDICAL INC |
6120 Windward Parkway |
Suite 220 |
Alpharetta,
GA
30005
|
|
Correspondent Contact |
Tanya Eberle |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 04/28/2010 |
Decision Date | 07/11/2011 |
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
|
|
|