V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE


Device Classification Name

set, administration, intravascular

510(k) Number K081289
Device Name V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
Applicant
BAXTER HEALTHCARE CORP.
1620 waukegan road
mcgaw park, 
IL 
60085

Applicant Contact nanette hedden
Correspondent
BAXTER HEALTHCARE CORP.
1620 waukegan road
mcgaw park, 
IL 
60085

Correspodent Contact nanette hedden
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 05/07/2008
Decision Date 08/04/2008
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

Yes