FDA 510(k) Applications for Medical Device:
Accessories, Catheter, G-U
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K051593 | ACMI CORPORATION |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K090121 | AVAIL MEDICAL PRODUCTS, INC. |
1900 EAST CARNEGIE AVE. | SANTA ANA | CA | 92705 |
| K112209 | AVAIL MEDICAL PRODUCTS, INC. |
5950 NANCY RIDGE ROAD | SAN DIEGO | CA | 92121 |
| K062240 | CHIEF MEDICAL LLC |
PO BOX 772 | TETON VILLAGE | WY | 83025 |
| K981611 | CIRCON CORP. |
6500 HOLLISTER AVE. | SANTA BARBARA | CA | 93117-3019 |
| K972977 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K032127 | HEMEDEX INCORPORATED |
7 TIFFANY TRAIL | HOPKINTON | MA | 01748 |
| K981667 | LAKE REGION MFG., INC. |
340 LAKE HAZELTINE DR. | CHASKA | MN | 55318 |
| K960866 | LAKE REGION MFG., INC. |
340 LAKE HAZELTINE DR. | CHASKA | MN | 55318 |
| K140562 | LEOMED, LLC |
9001 AIRPORT BLVD | HOUSTON | TX | 77061 |
| K954132 | MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. | NORTHBROOK | IL | 60062 |
| K981229 | MEDICAL DEVICE TECHNOLOGIES, INC. |
4445 SW 35TH TERRACE | GAINESVILLE | FL | 32608 |
| K991097 | MEDICAL DEVICE TECHNOLOGIES, INC. |
3600 SW 47TH AVENUE | GAINESVILLE | FL | 32608 |
| K000767 | MEMCATH TECHNOLOGIES LLC. |
1777 OAKDALE AVE. | WEST ST. PAUL | MN | 55118-4031 |
| K123170 | OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
136 TURNPIKE ROAD | SOUTHBOROUGH | MA | 01772 |
| K052134 | PERCUTANEOUS SYSTEMS, INC. |
1300 CRITTENDEN LANE | MOUNTAIN VIEW | CA | 94043-1359 |
| K042877 | PERCUTANEOUS SYSTEMS, INC. |
1300 CRITTENDEN LANE # 301 | MOUNTAIN VIEW | CA | 94043 |
| K040520 | PERCUTANEOUS SYSTEMS, INC. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K052298 | PERCUTANEOUS SYSTEMS, INCORPORATED |
1300 CRITTENDEN LANE | MOUNTAIN VIEW | CA | 94043-1359 |
| K042531 | PERCUTANEOUS SYSTEMS, INCORPORATED |
1300 CRITTENDEN LANE | MOUNTAIN VIEW | CA | 94043 |
| K052952 | PHYSICIAN TECHNOLOGIES, INC. |
4932 EAST HOLBROOK STREET | ANAHEIM | CA | 92807-1154 |
| K182144 | Promepla Sam |
9 Avenue Albert II | Monaco | 98000 | |
| K140441 | PROMEPLA SAM |
LE COPORI-9 AVENUE | MONACO | MC 9800 | |
| K120160 | PROMEPLA SAM |
LE COPORI-9 AVENUE | MONACO | MC 9800 | |
| K131803 | SOLACE THERAPEUTICS |
135 NEWBURY ST | FRAMINGHAM | MA | 01701 |
| K141252 | SOLACE THERAPEUTICS |
135 NEWBURY ST | FRAMINGHAM | MA | 01701 |
| K162356 | Solace Therapeutics |
135 Newbury St | Framingham | MA | 01701 |
| K023690 | WORLD METALS, INC, |
1020 NE 27 AVE. | POMPANO BEACH | FL | 33062 |
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