FDA 510(k) Application Details - K993995

Device Classification Name Syringe, Piston

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510(K) Number K993995
Device Name Syringe, Piston
Applicant VASCULAR TECHNOLOGIES LTD.
P.O.B. 454
GINOT SHOMRON 44853 IL
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Contact AHAVA STEIN
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 11/24/1999
Decision Date 02/14/2000
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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