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FDA 510(k) Application Details - K050464
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K050464
Device Name
Needle, Hypodermic, Single Lumen
Applicant
ULTI MED, INC.
5353 WAYZATA BLVD., STE 505
MINNEAPOLIS, MN 55414 US
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Contact
CAROLE STAMP
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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
02/23/2005
Decision Date
05/11/2005
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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