Device Classification Name |
External Mandibular Fixator And/Or Distractor
|
510(k) Number |
K080458 |
Device Name |
MIS CREST WIDENER |
Applicant |
MIS - IMPLANT TECHNOLOGIES LTD. |
POB 110 |
SHLOMI INDUSTRIAL ZONE |
SHLOMI,
IL
22832
|
|
Applicant Contact |
IMAN KHORSHID |
Correspondent |
MIS - IMPLANT TECHNOLOGIES LTD. |
POB 110 |
SHLOMI INDUSTRIAL ZONE |
SHLOMI,
IL
22832
|
|
Correspondent Contact |
IMAN KHORSHID |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 02/20/2008 |
Decision Date | 12/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|