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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 K984576
Device Name K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K
Applicant
Terumo Europe N.V.
Researchpark Zone 2
Interleuvenlaan 40
Leuven,  BE 3001
Applicant Contact M J AERTS
Correspondent
Terumo Europe N.V.
Researchpark Zone 2
Interleuvenlaan 40
Leuven,  BE 3001
Correspondent Contact M J AERTS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/23/1998
Decision Date 06/14/1999
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
Predetermined Change
Control Plan Authorized		 No
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