Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K973884 |
Device Name |
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE |
Applicant |
FRANTZ DESIGN, INC. |
400 MEDICAL CENTER, #209 |
WEBSTER,
TX
77598
|
|
Applicant Contact |
DONALD FRANTZ |
Correspondent |
FRANTZ DESIGN, INC. |
400 MEDICAL CENTER, #209 |
WEBSTER,
TX
77598
|
|
Correspondent Contact |
DONALD FRANTZ |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 10/14/1997 |
Decision Date | 01/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|