Device Classification Name |
Device, Finger-Sucking
|
510(k) Number |
K945537 |
Device Name |
T-GUARD |
Applicant |
MED ET AL DEVELOPMENT |
815 TADLOCK PL. |
MATTHEWS,
NC
28105
|
|
Applicant Contact |
E ZILBER |
Correspondent |
MED ET AL DEVELOPMENT |
815 TADLOCK PL. |
MATTHEWS,
NC
28105
|
|
Correspondent Contact |
E ZILBER |
Regulation Number | 890.3475
|
Classification Product Code |
|
Date Received | 11/14/1994 |
Decision Date | 03/23/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|