Device Classification Name |
barrier, synthetic, intraoral
|
510(k) Number |
K160493 |
Device Name |
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm |
Applicant |
Salvin Dental Specialties |
3450 Latrobe Drive |
Charlotte,
NC
28211
|
|
Applicant Contact |
Jennifer Singer |
Correspondent |
Kapstone Medical |
100 E. South Main St., PO Box 1458 |
Waxhaw,
NC
28173
|
|
Correspondent Contact |
John Kapitan |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 02/22/2016 |
Decision Date | 09/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|