Device Classification Name |
Barrier, Synthetic, Intraoral
|
510(k) Number |
K965205 |
Device Name |
TEFGEN - LS |
Applicant |
AMERICAN CUSTOM MEDICAL, INC. |
2430 NORTH 7TH AVE., #4 |
BOZEMAN,
MT
59715
|
|
Applicant Contact |
BRUCE G RUEFER |
Correspondent |
AMERICAN CUSTOM MEDICAL, INC. |
2430 NORTH 7TH AVE., #4 |
BOZEMAN,
MT
59715
|
|
Correspondent Contact |
BRUCE G RUEFER |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 12/26/1996 |
Decision Date | 04/30/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|