Device Classification Name |
Bone Grafting Material, Synthetic
|
510(k) Number |
K850012 |
Device Name |
ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO |
Applicant |
HEYLTEX CORP. |
10665 RICHMOND AVE. |
SUITE 192 |
HOUSTON,
TX
77042
|
|
Applicant Contact |
PARR |
Correspondent |
HEYLTEX CORP. |
10665 RICHMOND AVE. |
SUITE 192 |
HOUSTON,
TX
77042
|
|
Correspondent Contact |
PARR |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 01/02/1985 |
Decision Date | 04/22/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|