FDA 510(k) Application Details - K050654

Device Classification Name Kit, I.V. Start

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510(K) Number K050654
Device Name Kit, I.V. Start
Applicant AMSINO INTERNATIONAL, INC.
855 TOWNE CENTER DRIVE
POMONA, CA 91767 US
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Contact CHING CHING SEAH
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Regulation Number 000.0000

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Classification Product Code LRS
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Date Received 03/14/2005
Decision Date 05/02/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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