FDA 510(k) Application Details - K000369

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K000369
Device Name Needle, Hypodermic, Single Lumen
Applicant MEDPRO TECHNOLOGIES, INC.
962 ALLEGRO LN.
APOLLO BEACH, FL 33572 US
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Contact ART WARD
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 02/04/2000
Decision Date 03/30/2000
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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