Device Classification Name |
Specula Accessories
|
510(k) Number |
K891589 |
Device Name |
3MM DISPOSABLE SPECULA |
Applicant |
SEMANTODONTICS, INC. |
3400 EAST MCDOWELL RD. |
PHOENIX,
AZ
85008
|
|
Applicant Contact |
DANIEL F ENRIQUEZ |
Correspondent |
SEMANTODONTICS, INC. |
3400 EAST MCDOWELL RD. |
PHOENIX,
AZ
85008
|
|
Correspondent Contact |
DANIEL F ENRIQUEZ |
Regulation Number | 878.1800
|
Classification Product Code |
|
Date Received | 03/20/1989 |
Decision Date | 04/18/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|