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 |
| K231277 | DuraStat LLC |
1101 E 6th St Unit B | Austin | TX | 78702 |
| 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 |
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