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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 K120690
Device Name INSULIN PEN NEEDLE
Original Applicant
TIGER MEDICAL PRODUCTS LTD
1 huaihai zhong road
liu lin tower, suite 1910
shanghai,  CN 200021
Original Contact david wang
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/07/2012
Decision Date 06/22/2012
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
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