INFUSION ADAPTER C100


Device Classification Name

set, i.v. fluid transfer

510(k) Number K110023
Device Name INFUSION ADAPTER C100
Applicant
CARMEL PHARMA AB.
aminogatan 30
molndal, 

SE

s431 53

Applicant Contact kjell andreasson
Correspondent
CARMEL PHARMA AB.
aminogatan 30
molndal, 

SE

s431 53

Correspodent Contact kjell andreasson
Regulation Number 880.5440
Classification Product Code
LHI  
Date Received 01/03/2011
Decision Date 04/12/2011
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