BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015


Device Classification Name

set, blood transfusion

510(k) Number K023039
Device Name BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
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
BRZ  
Date Received 09/12/2002
Decision Date 11/07/2002
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