Device Classification Name |
Mouthguard, Prescription
|
510(k) Number |
K040315 |
Device Name |
MYOHEALTH CLENCHING INHIBITOR |
Applicant |
MCI-MYOHEALTH SYSTEMS |
26552 TAMPICO PLACE |
MISSION VIEJO,
CA
92691
|
|
Applicant Contact |
DAVID BALDING |
Correspondent |
MCI-MYOHEALTH SYSTEMS |
26552 TAMPICO PLACE |
MISSION VIEJO,
CA
92691
|
|
Correspondent Contact |
DAVID BALDING |
Classification Product Code |
|
Date Received | 02/09/2004 |
Decision Date | 08/27/2004 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|