Device Classification Name |
Mouthguard, Prescription
|
510(k) Number |
K022627 |
Device Name |
DSG RELAXER SPLINT |
Applicant |
SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP |
1801 K ST. NW |
SUITE 1200 |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
G. BRENT CONNOR |
Correspondent |
SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP |
1801 K ST. NW |
SUITE 1200 |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
G. BRENT CONNOR |
Classification Product Code |
|
Date Received | 08/07/2002 |
Decision Date | 03/18/2003 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|