FDA 510(k) Applications for Medical Device:
Needle, Assisted Reproduction
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991262 |
170 FORT PATH RD. | MADISON | CT | 06443 | |
| K991020 |
170 FORT PATH RD. | MADISON | CT | 06443 | |
| K991264 |
170 FORT PATH RD. | MADISON | CT | 06443 | |
| K190590 | Allwin Medical Devices, Inc. |
3305 E. Miraloma Avenue, Suite 176 | Anaheim | CA | 92806 |
| K991271 | CASMED UK |
39 NORK WAY BANSTEAD | SURREY | SM7 1PB | |
| K983593 | COOK OB/GYN |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K994417 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K182959 | CooperSurgical Inc. |
95 Corporate Drive | Trumbull | CT | 06611 |
| K023930 | COOPERSURGICAL, INC. |
P.O. BOX 2156 | HUNTINGTON | CT | 06484 |
| K191291 | CooperSurgical, Inc. |
95 Corporate Drive | Trumbull | CT | 06611 |
| K032208 | FERTILITY TECHNOLOGY RESOURCES, INC. |
4343 SHALLOWFORD RD. | MARIETTA | GA | 30062 |
| K013497 | GYNETICS MEDICAL PRODUCTS NV |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K051742 | INNTEC, INC. |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K162881 | Kitazato Corporation |
1-1-8 Shibadaimon, Minato-ku | Tokyo | 105-0012 | |
| K112462 | KITAZATO MEDICAL CO., LTD. |
611 WEST 5TH STREET | AUSTIN | TX | 78701 |
| K990913 | LABORATOIRES PRODIMED |
23 WELISEWITZ RD. | RINGOES | NJ | 08551 |
| K003056 | LABOTECT LABOR-TECHNIK GOTTINGEN |
WILLI-EICHLER-STR. 25 | GOTTINGEN | D-37079 | |
| K992308 | LIFETEK MEDICAL, INC. |
P.O. BOX 560 | STILLWATER | MN | 55082 |
| K031622 | PORTEX LTD. |
MILITARY ROAD | ENGLAND CT21 6DB | ||
| K000205 | ROCKET MEDICAL PLC |
WARE INDUSTRIAL ESTATE | WASHINGTON, TYNE & WEAR | NE37 1NE | |
| K032015 | ROCKET MEDICAL PLC |
WEAR INDUSTRIAL ESTATE | WASHINGTON, TYNE & WEAR | NE38 9BZ | |
| K240523 | Shenzhen VitaVitro Biotech Co., Ltd. |
R601, Building B, Hai Ke Xing Tech Park | Shenzhen | 518118 | |
| K000628 | SIMS PORTEX LTD. |
HYTHE | KENT | CT21 6JL | |
| K012068 | SIMS PORTEX LTD. |
HYTHE | HYTHE, KENT | CT 21 6JL | |
| K991273 | SWEMED LAB INTERNATIONAL AB |
555 13TH ST. N.W. | WASHINGTON | DC | 20004 |
| K161970 | VITROLIFE SWEDEN AB |
GUSTAF WERNERS GATA 2 | VASTRA FROLUNDA | SE-421 32 | |
| K082727 | VITROLIFE SWEDEN AB |
FAKTORVAGEN 13 | KUNGSBACKA | SE-434 37 | |
| K172050 | Vitrolife Sweden AB |
Gustaf Werners gata 2 | Vastra Frolunda | SE-42132 | |
| K171611 | William A. Cook Australia Pty Ltd |
95 Brandl Street | Eight Mile Plains | 4113 | |
| K141365 | WILLIAM A. COOK AUSTRALIA PTY, LTD. |
95 BRANDL ST | EIGHT MILE PLAINS, QUEENSLAND | 4113 | |
| K171625 | Willian A. Cook Australia Pty Ltd |
95 Brandl Street | Eight Mile Plains | 4113 | |
| K232163 | Zhejiang Horizon Medical Technology Co., Ltd. |
Room 219, 2nd floor, Building 9, 1303 Asia-Pacific Road | Jiaxing | 314006 |
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