SAFE’SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM


Device Classification Name

syringe, antistick

510(k) Number K112936
Device Name SAFE’SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
Applicant
REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA
800 corp. grove dr.
buffalo grove, 
IL 
60089

Applicant Contact sandra anderson
Correspondent
REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA
800 corp. grove dr.
buffalo grove, 
IL 
60089

Correspodent Contact sandra anderson
Regulation Number 880.5860
Classification Product Code
MEG  
Date Received 10/03/2011
Decision Date 01/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No