Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K102684 |
Device Name |
XELIS DENTAL |
Applicant |
INFINITT CO., LTD. |
12F DAERUNG POST TOWER III |
182-4 GURO-DONG, GURO-GU |
SEOUL,
KR
152-050
|
|
Applicant Contact |
TRISTAN CHOI |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONRY |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/17/2010 |
Decision Date | 10/01/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|