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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K101054
Device Name ROMIAPEX MODEL A-15
Applicant
Romidan, Ltd.
5 Simcha Holzberg St.
Kiryat-Ono,  IL 55022
Applicant Contact EITAN MARGALIT
Correspondent
Romidan, Ltd.
5 Simcha Holzberg St.
Kiryat-Ono,  IL 55022
Correspondent Contact EITAN MARGALIT
Classification Product Code
LQY  
Date Received04/15/2010
Decision Date 09/03/2010
Decision Substantially Equivalent (SESE)
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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