Device Classification Name |
Barrier, Synthetic, Intraoral
|
510(k) Number |
K171774 |
Device Name |
RPM Reinforced PTFE Mesh |
Applicant |
Osteogenics Biomedical, Inc. |
4620 71st St. Bldg. 78-79 |
Lubbock,
TX
79424
|
|
Applicant Contact |
Shane Shuttlesworth |
Correspondent |
Osteogenics Biomedical, Inc. |
4620 71st St. Bldg. 78-79 |
Lubbock,
TX
79424
|
|
Correspondent Contact |
Shane Shuttlesworth |
Regulation Number | 872.3930
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/14/2017 |
Decision Date | 10/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|