Device Classification Name |
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
More FDA Info for this Device |
510(K) Number |
K163049 |
Device Name |
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
Applicant |
Antarma dba Golnit Sutures
1204 Avenue U, #2030
Brooklyn, NY 11229 US
Other 510(k) Applications for this Company
|
Contact |
Armine Badalyan
Other 510(k) Applications for this Contact |
Regulation Number |
878.5035
More FDA Info for this Regulation Number |
Classification Product Code |
NBY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/01/2016 |
Decision Date |
06/21/2017 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
SU - General & Plastic Surgery |
Review Advisory Committee |
SU - General & Plastic Surgery |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|