Device Classification Name |
diagnostic light, soft tissue detector
|
510(k) Number |
K070523 |
Device Name |
MODIFICATION TO: VELSCOPE |
Applicant |
LED DENTAL INC. |
#201-15047 MARINE DR. |
WHITE ROCK, BRITISH COLUMBIA,
CA
V4B 1C5
|
|
Applicant Contact |
DAVID C MORGAN, PHD |
Correspondent |
LED DENTAL INC. |
#201-15047 MARINE DR. |
WHITE ROCK, BRITISH COLUMBIA,
CA
V4B 1C5
|
|
Correspondent Contact |
DAVID C MORGAN, PHD |
Regulation Number | 872.6350
|
Classification Product Code |
|
Date Received | 02/23/2007 |
Decision Date | 04/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|