CYTOGUARD(TM) CLOSED LUER CONNECTOR


Device Classification Name

set, administration, intravascular

510(k) Number K112636
Device Name CYTOGUARD(TM) CLOSED LUER CONNECTOR
Applicant
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Applicant Contact angela j caravella
Correspondent
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Correspodent Contact angela j caravella
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 09/09/2011
Decision Date 11/26/2011
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