SURECAN SAFETY HUBER NEEDLE INFUSION SETS


Device Classification Name

set, administration, intravascular

510(k) Number K021488
Device Name SURECAN SAFETY HUBER NEEDLE INFUSION SETS
Original Applicant
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Original Contact sheri l masgnung
Regulation Number 880.5440
Classification Product Code
FPA  
Subsequent Product Code
LJT  
Date Received 05/08/2002
Decision Date 07/08/2002
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