Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K991948 |
Device Name |
DR. B'S MOUTHPIECE, MODEL 32129-10002 |
Applicant |
SNORE - EZZER |
1217 SO. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
ROBERT A GALL |
Correspondent |
SNORE - EZZER |
1217 SO. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
ROBERT A GALL |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 06/09/1999 |
Decision Date | 09/02/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|