FDA 510(k) Application Details - K962040

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K962040
Device Name Needle, Hypodermic, Single Lumen
Applicant CONTOUR FABRICATORS OF FLORIDA, INC.
40178 U.S. 19 NORTH
TARPON SPRINGS, FL 34689 US
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Contact PAT LAMB
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 05/24/1996
Decision Date 06/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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