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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K972823 | A & A MEDICAL, INC. |
4100 NINE MCFARLAND DR., #B | ALPHARETTA | GA | 30201 |
| K972245 | A & A MEDICAL, INC. |
4100 NINE MCFARLAND DR., #B | ALPHARETTA | GA | 30201 |
| K940176 | ACKRAD LABORATORIES |
70 JACKSON DR. | CRANFORD | NJ | 07016 |
| K963031 | GENX INTL., INC. |
339 BARTLETT DR. | MADISON | CT | 06443 |
| K970750 | IMAGYN MEDICAL, INC. |
27651 LA PAZ RD. | LAGUNA NIGUEL | CA | 92656-3917 |
| K021438 | LABOTECT LABOR-TECHNIK GOTTINGEN |
WILLI-EICHLER-STR. 25 | GOTTINGEN | D-37079 | |
| K962273 | MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. | WILLOUGHBY | OH | 44094 |
| K964848 | MARLOW SURGICAL TECHNOLOGIES, INC. |
1810 JOSEPH LLOYD PKWY. | WILLOUGHBY | OH | 44094 |
| K982628 | MEDWORKS CORP. |
50 BREWSTER ST. | PAWTUCKET | RI | 02860 |
| K982630 | MEDWORKS CORP. |
50 BREWSTER ST. | PAWTUCKET | RI | 02860 |
| K980061 | ROCKET MEDICAL PLC |
1151 HOPE ST. | STAMFORD | CT | 06907 |
| K012935 | SELECT MEDICAL SYSTEMS, INC. |
P.O. BOX 966 | WILLISTON | VT | 05495-0966 |
| K984306 | WALLACH SURGICAL DEVICES, INC. |
235 EDISON RD. | ORANGE | CT | 06477 |