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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Contact 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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