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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K100436
Device Name CLICKFINE PEN NEEDLE
Applicant
YPSOMED AG
BRUNNMATTSTRASSE 6
BURGDORF,  CH CH-3401
Applicant Contact MANFRED MADER
Correspondent
YPSOMED AG
BRUNNMATTSTRASSE 6
BURGDORF,  CH CH-3401
Correspondent Contact MANFRED MADER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/16/2010
Decision Date 04/30/2010
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
Predetermined Change
Control Plan Authorized		 No
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