BURETTE-IN LINE (150 ML)


Device Classification Name

set, administration, intravascular

510(k) Number K023595
Device Name BURETTE-IN LINE (150 ML)
Original Applicant
TUTA HEALTHCARE PTY LIMITED
318-332 burns bay road
lane cove
sydney nsw, 

AU

2066

Original Contact omid souresrafil
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 10/28/2002
Decision Date 12/18/2002
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