BD AUTOSHIELD DUO PEN NEEDLE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K110703
Device Name BD AUTOSHIELD DUO PEN NEEDLE
Applicant
Becton, Dickinson and Company
1 becton drive mc 372
franklin lakes, 
NJ 
07417

Applicant Contact cynthia lacatena
Correspondent
Becton, Dickinson and Company
1 becton drive mc 372
franklin lakes, 
NJ 
07417

Correspodent Contact cynthia lacatena
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 03/14/2011
Decision Date 07/27/2011
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