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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 K141749
Device Name CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
Applicant
FACET TECHNOLOGIES, LLC
112 TOWN PARK DR.
SUITE 300
KENNESAW,  GA  30144
Applicant Contact JENNIFER REGISTER
Correspondent
FACET TECHNOLOGIES, LLC
112 TOWN PARK DR.
SUITE 300
KENNESAW,  GA  30144
Correspondent Contact JENNIFER REGISTER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/30/2014
Decision Date 07/29/2014
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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