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 |
|
Date Received | 04/15/2010 |
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
|
|
|