NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)


Device Classification Name

pump, infusion

510(k) Number K112067
Device Name NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
Applicant
CARTICEPT MEDICAL INC
6120 windward prkwy
suite 220
alpharetta, 
GA 
30005

Applicant Contact tanya eberle
Correspondent
CARTICEPT MEDICAL INC
6120 windward prkwy
suite 220
alpharetta, 
GA 
30005

Correspodent Contact tanya eberle
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 07/19/2011
Decision Date 09/16/2011
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