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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
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