Device Classification Name |
Unit, Operative Dental
|
510(k) Number |
K974487 |
Device Name |
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 |
Applicant |
ASI MEDICAL, INC. |
14550 EAST EASTER AVE. |
SUITE 700 |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
JOHN W MCPEEK |
Correspondent |
ASI MEDICAL, INC. |
14550 EAST EASTER AVE. |
SUITE 700 |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
JOHN W MCPEEK |
Regulation Number | 872.6640
|
Classification Product Code |
|
Date Received | 11/26/1997 |
Decision Date | 02/18/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|