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FDA 510(k) Application Details - K080235
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K080235
Device Name
Needle, Hypodermic, Single Lumen
Applicant
GREINER BIO-ONE VACUETTE NORTH AMERICA
13801 ECK ROAD
HYDES, MD 21082 US
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Contact
JUDITH SMITH
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
01/30/2008
Decision Date
04/24/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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