Device Classification Name |
Device, Caries Detection
|
510(k) Number |
K913405 |
Device Name |
KAR-D-TEK |
Applicant |
GRESCO PRODUCTS, INC. |
P.O. BOX 865 |
12603 EXECUTIVE DR. #814 |
STAFFORD,
TX
77497
|
|
Applicant Contact |
CLINTON D VAUPEL |
Correspondent |
GRESCO PRODUCTS, INC. |
P.O. BOX 865 |
12603 EXECUTIVE DR. #814 |
STAFFORD,
TX
77497
|
|
Correspondent Contact |
CLINTON D VAUPEL |
Regulation Number | 872.1740
|
Classification Product Code |
|
Date Received | 07/30/1991 |
Decision Date | 10/28/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|