ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG


Device Classification Name

set, administration, intravascular

510(k) Number K073396
Device Name ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
Applicant
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Applicant Contact rebecca stolarick
Correspondent
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Correspodent Contact rebecca stolarick
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 12/03/2007
Decision Date 08/07/2008
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

No