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FDA 510(k) Application Details - K954500
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K954500
Device Name
Needle, Hypodermic, Single Lumen
Applicant
HOSPITEC, INC.
635 PRIOR AVE. NORTH
SAINT PAUL, MN 55104 US
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NIC ORR
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Regulation Number
880.5570
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Classification Product Code
FMI
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Date Received
09/28/1995
Decision Date
01/18/1996
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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