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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 K082820
Device Name K-PACK II NEEDLE - 29G THIN WALL
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 Received09/25/2008
Decision Date 10/23/2008
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
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