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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 K122969
Device Name CLICKFINE PEN NEEDLE
Applicant
P/L Biomedical
10882 Stonigton Ave.
Fort Myers,  FL  33913
Applicant Contact Lee Leichter
Correspondent
P/L Biomedical
10882 Stonigton Ave.
Fort Myers,  FL  33913
Correspondent Contact Lee Leichter
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/26/2012
Decision Date 10/25/2012
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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