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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 K062608
Device Name 29G AND 30G K-PACK II NEEDLE
Applicant
Terumo Europe N.V.
Interleuvenlaan 40
Researchpark Zone 2
Leuven,  BE 3001
Applicant Contact M.J. AERTS
Correspondent
Terumo Europe N.V.
Interleuvenlaan 40
Researchpark Zone 2
Leuven,  BE 3001
Correspondent Contact M.J. AERTS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/05/2006
Decision Date 09/15/2006
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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