FDA 510(k) Application Details - K052103

Device Classification Name Syringe, Antistick

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510(K) Number K052103
Device Name Syringe, Antistick
Applicant EXELINT INTL. CO.
5840 WEST CENTINELA AVE.
LOS ANGELES, CA 90045 US
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Contact ARMAND HAMID
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 08/03/2005
Decision Date 10/19/2005
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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