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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 3001,  BE 3001
Applicant Contact M J AERTS
Correspondent
TERUMO EUROPE N.V.
RESEARCHPARK ZONE 2
INTERLEUVENLAAN 40
LEUVEN 3001,  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
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