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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 K110850
Device Name K-PACK II NEEDLE- 27G & 30G THIN WALL
Applicant
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3001
Applicant Contact M.J. AERTS
Correspondent
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3001
Correspondent Contact M.J. AERTS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/28/2011
Decision Date 06/09/2011
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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