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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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More FDA Info for this Product Code
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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