Device Classification Name |
Prosthesis, Condyle, Mandibular, Temporary
|
510(k) Number |
K002790 |
Device Name |
ADD-ON CONDYLE |
Applicant |
WALTER LORENZ SURGICAL, INC. |
11520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218 -2480
|
|
Applicant Contact |
TREVOR BYRD |
Correspondent |
WALTER LORENZ SURGICAL, INC. |
11520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218 -2480
|
|
Correspondent Contact |
TREVOR BYRD |
Regulation Number | 872.4770
|
Classification Product Code |
|
Date Received | 09/07/2000 |
Decision Date | 08/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|