FDA 510(k) Application Details - K020500

Device Classification Name

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510(K) Number K020500
Device Name UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
Applicant UNIVEC, INC.
22 DUBON CT.
FARMINGDALE, NY 11735 US
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Contact R. COHEN
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Regulation Number

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Classification Product Code SCL
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Date Received 02/14/2002
Decision Date 03/19/2002
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

FDA Source Information for K020500


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