PHASEAL


Device Classification Name

set, i.v. fluid transfer

510(k) Number K023747
Device Name PHASEAL
Original Applicant
CARMEL PHARMA AB.
box 5352
gothenburg, 

SE

40228

Original Contact kjell andreasson
Regulation Number 880.5440
Classification Product Code
LHI  
Date Received 11/08/2002
Decision Date 11/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No