Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K101252 |
Device Name |
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 |
Applicant |
NEOTRACT, INC. |
4473 WILLOW ROAD |
SUITE 100 |
PLEASANTON,
CA
94588
|
|
Applicant Contact |
KEVIN MACDONALD |
Correspondent |
NEOTRACT, INC. |
4473 WILLOW ROAD |
SUITE 100 |
PLEASANTON,
CA
94588
|
|
Correspondent Contact |
KEVIN MACDONALD |
Regulation Number | 878.5000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/04/2010 |
Decision Date | 07/15/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|