CLICKFINE AUTOPROTECT PEN NEEDLE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K110312
Device Name CLICKFINE AUTOPROTECT PEN NEEDLE
Applicant
YPSOMED AG
brunnmattstrasse 6
burgdorf, 

CH

ch-3401

Applicant Contact andre sauter
Correspondent
YPSOMED AG
brunnmattstrasse 6
burgdorf, 

CH

ch-3401

Correspodent Contact andre sauter
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 02/02/2011
Decision Date 01/26/2012
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