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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Drainage, Intraoral/Extraoral
510(k) Number K072334
Device Name SIALO DRAIN
Applicant
Sialo Technology, Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Sialo Technology, Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number878.4200
Classification Product Code
OAJ  
Date Received08/20/2007
Decision Date 07/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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