Device Classification Name |
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
More FDA Info for this Device |
510(K) Number |
K192088 |
Device Name |
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
Applicant |
Antarma LLC dba Golnit Sutures
276 5th Ave., Suite 704
New York, NY 10001 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 |
08/05/2019 |
Decision Date |
09/04/2019 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
SU - General & Plastic Surgery |
Review Advisory Committee |
SU - General & Plastic Surgery |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|