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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K014249
Device Name JETPOLISHER
Applicant
Deldent , Ltd.
19 Keren Kayemet St.
Petach Tikvah,  IL 49372
Applicant Contact ALAN EDEL
Correspondent
Deldent , Ltd.
19 Keren Kayemet St.
Petach Tikvah,  IL 49372
Correspondent Contact ALAN EDEL
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received12/26/2001
Decision Date 02/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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