Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K073004 |
Device Name |
SOMNOMED BFLEX |
Applicant |
SOMNOMED INC. |
3537 TEASLEY LANE |
DENTON,
TX
76210
|
|
Applicant Contact |
ASHLEY TRUITT |
Correspondent |
SOMNOMED INC. |
3537 TEASLEY LANE |
DENTON,
TX
76210
|
|
Correspondent Contact |
ASHLEY TRUITT |
Regulation Number | 872.5570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/24/2007 |
Decision Date | 01/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|