Device Classification Name |
block, bite
|
510(k) Number |
K992269 |
Device Name |
VENTIL-A ORAL PROTECTOR |
Applicant |
SOMATICS, INC. |
910 SHERWOOD DR., UNIT 17 |
LAKE BLUFF,
IL
60044
|
|
Applicant Contact |
RICHARD ABRAMS |
Correspondent |
SOMATICS, INC. |
910 SHERWOOD DR., UNIT 17 |
LAKE BLUFF,
IL
60044
|
|
Correspondent Contact |
RICHARD ABRAMS |
Regulation Number | 882.5070
|
Classification Product Code |
|
Date Received | 07/06/1999 |
Decision Date | 10/25/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|