Device Classification Name |
barrier, synthetic, intraoral
|
510(k) Number |
K151344 |
Device Name |
Cytoflex Tefguard Ti-Enforced Membrane |
Applicant |
Unicare Biomedical, Inc. |
23011 Moulton Parkway, J-11 |
Laguna Hills,
CA
92653
|
|
Applicant Contact |
Stan Yang |
Correspondent |
Unicare Biomedical, Inc. |
23011 Moulton Parkway, J-11 |
Laguna Hills,
CA
92653
|
|
Correspondent Contact |
Stan Yang |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 05/19/2015 |
Decision Date | 11/19/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|