Device Classification Name |
unit, operative dental
|
510(k) Number |
K043325 |
Device Name |
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES |
Applicant |
ROLENCE ENTEPRISE, INC. |
18-3, LANE 231 |
PU-CHUNG ROAD |
CHUNGI,
TW
320
|
|
Applicant Contact |
STERLING CHENG |
Correspondent |
ROLENCE ENTEPRISE, INC. |
18-3, LANE 231 |
PU-CHUNG ROAD |
CHUNGI,
TW
320
|
|
Correspondent Contact |
STERLING CHENG |
Regulation Number | 872.6640
|
Classification Product Code |
|
Date Received | 12/02/2004 |
Decision Date | 02/11/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|