FDA 510(k) Application Details - K072334

Device Classification Name Catheter, Drainage, Intraoral/Extraoral

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510(K) Number K072334
Device Name Catheter, Drainage, Intraoral/Extraoral
Applicant SIALO TECHNOLOGY, LTD.
20 HATA'AS ST.
KFAR SABA 44425 IL
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Contact AHAVA STEIN
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Regulation Number 878.4200

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Classification Product Code OAJ
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Date Received 08/20/2007
Decision Date 07/18/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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