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FDA 510(k) Application Details - K000657
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K000657
Device Name
Needle, Hypodermic, Single Lumen
Applicant
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE, IL 60073 US
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Contact
MARY ELLEN SNYDER
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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
02/28/2000
Decision Date
03/08/2000
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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