FDA 510(k) Applications for Medical Device:
Catheter, Assisted Reproduction
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991266 |
170 FORT PATH RD. | MADISON | CT | 06443 | |
| K200248 | Allwin Medical Devices, Inc. |
3305 East Mira Loma Avenue, STE 176 | Anaheim | CA | 92806 |
| K190522 | Allwin Medical Devices, Inc. |
3305 E. Miraloma Avenue, Suite 176 | Anaheim | CA | 92806 |
| K120154 | CATHETER RESEARCH, INC. |
5610 W 82ND ST | INDIANAPOLIS | IN | 46278 |
| K173686 | Cook Incorporated |
750 Daniels Way P.O. Box 489 | Bloomington | IN | 47402 |
| K180302 | Cook Incorporated |
750 Daniels Way P.O. Box 489 | Bloomington | IN | 47402 |
| K172051 | Cook Incorporated |
750 Daniels Way, P.O. Box 489 | Bloomington | IN | 47402 |
| K173103 | Cook Incorporated |
750 Daniels Way, P.O. Box 489 | Bloomington | IN | 47402-0489 |
| K172321 | Cook Incorporated |
750 Daniels Way P.O. Box 489 | Bloomington | IN | 47402 |
| K191015 | Cook Incorporated |
750 Daniels Way P.O. Box 489 | Bloomington | IN | 47402 |
| K163318 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K983594 | COOK OB/GYN |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K983590 | COOK OB/GYN |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K983587 | COOK OB/GYN |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K983591 | COOK OB/GYN |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K983595 | COOK OB/GYN |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K023379 | COOPER SURGICAL |
P.O. BOX 2156 | HUNTINGTON | CT | 06484 |
| K023383 | COOPER SURGICAL |
P.O. BOX 2156 | HUNTINGTON | CT | 06484 |
| K023382 | COOPER SURGICAL |
P.O. BOX 2156 | HUNTINGTON | CT | 06484 |
| K023384 | COOPER SURGICAL |
P.O. BOX 2156 | HUNTINGTON | CT | 06484 |
| K990350 | COOPERSURGICAL, INC. |
15 FOREST PKWY. | SHELTON | CT | 06484 |
| K990349 | COOPERSURGICAL, INC. |
15 FOREST PKWY. | SHELTON | CT | 06484 |
| K990348 | COOPERSURGICAL, INC. |
15 FOREST PKWY. | SHELTON | CT | 06484 |
| K162064 | CrossBay Medical Inc. |
13240 Evening Creek Drive, Suite 304 | San Diego | CA | 92128 |
| K231730 | Femasys Inc. |
3950 Johns Creek CT. | Suwanee | GA | 30024 |
| K141666 | FERTILIGENT, LTD |
5610 W 82ND ST | INDIANAPOLIS | IN | 46278 |
| K092579 | FERTILIGENT, LTD |
5610 W 82ND ST | INDIANAPOLIS | IN | 46278 |
| K992307 | FERTILITY TECHNOLOGY RESOURCES, INC. |
4343 SHALLOWFORD RD. | MARIETTA | GA | 30062 |
| K041470 | FERTILITY TECHNOLOGY RESOURCES, INC. |
4343 SHALLOWFORD RD. | MARIETTA | GA | 30062 |
| K023017 | FERTILITY TECHNOLOGY RESOURCES, INC. |
4343 SHALLOWFORD RD. | MARIETTA | GA | 30062 |
| K013536 | GYNETICS MEDICAL PRODUCTS NV |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K013501 | GYNETICS MEDICAL PRODUCTS NV |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K050521 | INNTEC, INC. |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K052059 | INNTEC, INC. |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K162878 | Kitazato Corporation |
1-1-8 Shibadaimon, Minato-ku | Tokyo | 105-0012 | |
| K192540 | Kitazato Corporation |
Shibakoen Building, 1-1-8 Shibadaimon, Minato-ku | Tokyo | 105-0012 | |
| K162667 | Kitazato Corporation |
1-1-8 Shibadaimon, Minato-ku | Tokyo | ||
| K112396 | KITAZATO MEDICAL CO., LTD. |
611 WEST 5TH STREET | AUSTIN | TX | 78701 |
| K131491 | KITAZATO MEDICAL CO., LTD. |
816 CONGRESS AVE. STE. 1400 | AUSTIN | TX | 78701 |
| K000950 | LABOTECT LABOR-TECHNIK GOTTINGEN |
WILLI-EICHLER-STR. 25 | GOTTINGEN | D-37079 | |
| K143669 | MEDGYN PRODUCTS, INC. |
100 W. Industrial Rd. | Addison | IL | 60101 |
| K161547 | ORIGIO A/S |
KNARDRUPVEJ 2 | MAALOEV | 2760 | |
| K033084 | PORTEX LTD. |
MILITARY ROAD | HYTHE, KENT | CT21 6DB | |
| K000656 | ROCKET MEDICAL PLC |
WARE INDUSTRIAL ESTATE | WASHINGTON, TYNE & WEAR | NE37 1NE | |
| K994327 | ROCKET MEDICAL PLC |
TYNE & WEAR | WASHINGTON | NE37 1NE | |
| K220010 | Shanghai Horizon Medical Technology Co., Ltd. |
Room 401, Building #24, No. 1-28, 588 Tianxiong Rd | Shanghai | 201318 | |
| K240307 | Shenzhen VitaVitro Biotech Co., Ltd. |
R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No.16, | Shenzhen | 518118 | |
| K053208 | SWEMED LAB INTERNATIONAL AB |
BILLDALSVAGEN 2 | BILLDAL | SE-427 36 | |
| K012220 | TTJ BIOMEDICAL, LLC. |
2885 AURORA AVENUE, SUITE 15 | BOULDER | CO | 80303 |
| K243373 | Vitrolife Sweden AB |
Gustaf Werners gata 2 | Gothenburg | ||
| K983604 | WASHINGTON REGULATORY SERVICES |
23 WELISEWITZ RD. | RINGOES | NJ | 08551 |
| K173431 | William A. Cook Australia PTY LTD |
95 Brandl Street | Eight Mile Plains | 4113 |
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