FDA 510(k) Applications for Medical Device:
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K163049 |
Antarma dba Golnit Sutures |
1204 Avenue U, #2030
| Brooklyn |
NY |
11229 |
K192088 |
Antarma LLC dba Golnit Sutures |
276 5th Ave., Suite 704
| New York |
NY |
10001 |
K173922 |
CP Medical Inc. |
1775 Corporate Dr.
| Norcross |
GA |
30093 |
K181578 |
Demetech Corporation |
14175 NW 60th Ave.
| Miami Lakes |
FL |
33104 |
K173335 |
Dura Tap LLC |
208 Upland Way
| Wayne |
PA |
19087 |
K170842 |
Foosin Medical Supplies Inc., Ltd. |
No.20, Xingshan Road, Weihai Torch Hi-tech Science Park
| Weihai |
|
264210 |
K163639 |
LSI SOLUTIONS |
7796 VICTOR-MENDON RD
| VICTOR |
NY |
14564 |
K180630 |
OMNIA SPA |
Via F. Delnevo, 190
| Fidenza |
|
43036 |
K132464 |
OMNIA SPA |
VIA SARAGAT 5
| IMOLA, BO |
|
40026 |
K191317 |
Origami Surgical |
42 Main St. Suite A
| Madison |
NJ |
07940 |
K123811 |
ORIGAMI SURGICAL LLC |
79 HAVEN ST.
| DOVER |
MA |
02030 |
K072076 |
OSTEOGENICS BIOMEDICAL, INC. |
4620 71ST ST., BLDG. 78-79
| LUBBOCK |
TX |
79424 |
K003028 |
OSTEOGENICS BIOMEDICAL, INC. |
3234 64TH ST.
| LUBBOCK |
TX |
79413 |
K180992 |
Purgo Biologics Inc. |
E-607, 700, Pangyo-ro
| Seongnam-si |
|
13516 |
K140415 |
RIVERPOINT MEDICAL |
825 NE 25TH AVE.
| PORTLAND |
OR |
97232 |
K160744 |
Surgical Specialties Corporation |
Corredor Tijuana-Rosarito 2000, #24702-B
| Tijuana |
|
22235 |
|
|