FDA 510(k) Applications for Medical Device:
System, Perfusion, Kidney
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K203262 | Bridge to Life Ltd. |
128 Suber Rd., Suite A | Columbia | SC | 29210 |
| K191006 | Bridge to Life Ltd. |
128 Suber Rd. Suite A | Columbia | SC | 29210 |
| K992209 | DR. FRANZ KOHLER CHEMIE GMBH |
12300 TWINBROOK PKWY. | ROCKVILLE | MD | 20852 |
| K211224 | Institut Georges Lopez |
Parc Tertiaire Du Bois Dieu, 1 Allee des Chevreuils | Lissieu | 69380 | |
| K990229 | JUSTEC MEDICAL PRODUCTS, INC. |
1724 CHURCH ST. | HOLBROOK | NY | 11741 |
| K013575 | ORGAN RECOVERY SYSTEMS, INC. |
701 EAST BAY ST. | CHARLESTON | SC | 29403 |
| K021362 | ORGAN RECOVERY SYSTEMS, INC. |
701 EAST BAY ST. | CHARLESTON | SC | 29403 |
| K022391 | ORGAN RECOVERY SYSTEMS, INC. |
701 EAST BAY ST. | CHARLESTON | SC | 29466 |
| K223874 | Paragonix Technologies |
Suite 408, 639 Granite St. | Braintree | MA | 02184 |
| K191440 | Paragonix Technologies |
Suite 408, 639 Granite St. | Braintree | MA | 02184 |
| K201048 | Paragonix Technologies |
Suite 408, 639 Granite Street | Braintree | MA | 02184 |
| K143054 | PARAGONIX TECHNOLOGIES, INC. |
639 GRANITE STREET | BRAINTREE | MA | 02184 |
| K133694 | PARAGONIX TECHNOLOGIES, INC. |
93 BENEFIT STREET | PROVIDENCE | RI | 02904 |
| K192869 | Pragonix Technologies |
Suite 408, 639 Granite Street | Braintree | MA | 02184 |
| K073693 | PRESERVATION SOLUTIONS, INC. |
4250 GROVE STREET | DENVER | CO | 80211 |
| K083453 | PRESERVATION SOLUTIONS, INC. |
4250 GROVE STREET | DENVER | CO | 80211 |
| K091245 | PRESERVATION SOLUTIONS, INC. |
4250 GROVE STREET | DENVER | CO | 80211 |
| K151728 | PRESERVATION SOLUTIONS, INC. |
1099 PROCTOR DRIVE | ELKHORN | WI | 53121 |
| K080432 | PRESERVATION SOLUTIONS, INC. |
4250 GROVE STREET | DENVER | CO | 80211 |
| K180481 | S.A.L.F. spa |
Via Marconi 2 | Cenate Sotto | 24069 | |
| K230193 | S.A.L.F. spa |
Via Marconi 2 | Cenate Sotto | 24069 | |
| K202652 | S.A.L.F. spa |
Via Marconi 2 | Cenate Sotto | 24069 | |
| K972066 | TRANS-MED CORP. |
230 EVANS AVE. | ELK RIVER | MN | 55330 |
| K153384 | United Therapeutics Corporation |
55 TW Alexander Drive, PO Box 14186 | Research Triangle Park | NC | 27709 |
| K042224 | WATERS INSTRUMENTS, INC. |
13705 26TH AVENUE N. | MINNEAPOLIS | MN | 55441-3644 |
| K971571 | WATERS INSTRUMENTS, INC. |
2411 SEVENTH ST. N.W. | ROCHESTER | MN | 55903-6117 |
| K111521 | WATERS MEDICAL SYSTEMS, LLC |
2112 15TH ST. N.W., SUITE A | ROCHESTER | MN | 55901-0716 |
| K211333 | XVIVO Perfusion AB |
MΣssans Gata 10 | Goteborg | 41251 | |
| K091989 | XVIVO PERFUSION AB |
BOX 9080 | GOTEBORG | SE-40092 | |
| K170826 | XVIVO Perfusion AB |
| Goteborg |
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