FDA 510(k) Application Details - K955772

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K955772
Device Name Needle, Hypodermic, Single Lumen
Applicant TTK BIOMED, LTD.
1575 EYE STREET, N.W.
WASHINGTON, DC 20005 US
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Contact RICHARD D MANTHEI
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 12/21/1995
Decision Date 07/08/1996
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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