FDA 510(k) Applications for Medical Device:
Generator, Lesion, Radiofrequency
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K203293 | Abbott Medical |
5050 Nathan Lane | Plymouth | MN | 55442 |
| K201610 | Abbott Medical |
5050 Nathan Lane | Plymouth | MN | 55442 |
| K063753 | ACI, INC. |
555 ZANG STREET | DENVER | CO | 80228 |
| K192491 | Avanos Medical, Inc. |
5405 Windward Parkway, Suite 100 | Alpharetta | GA | 30004 |
| K020354 | BAYLIS MEDICAL CO., INC. |
5160 EXPLORER DRIVE, UNIT 33 | MISSISSAUGA, ONTARIO | L4W-4T7 | |
| K002565 | BAYLIS MEDICAL CO., INC. |
5160 EXPLORER DRIVE, UNIT 5 | MISSISSAUGA | L4W-4T7 | |
| K181864 | Baylis Medical Company Inc. |
2775 Matheson Blvd. East | Mississauga | L4W 4P7 | |
| K081729 | BIOFORM MEDICAL, INC. |
4133 COURTNEY ROAD, #10 | FRANKSVILLE | WI | 53126 |
| K101592 | CHENG MEDICAL, CORPORATION |
12945 SARATOGA AVE | SARATOGA | CA | 95070 |
| K082051 | COSMAN MEDICAL, INC. |
76 CAMBRIDGE ST. | BURLINGTON | MA | 01803-4140 |
| K021869 | DIROS TECHNOLOGY, INC. |
1837 KEMPTON RD. | CHARLESTON | SC | 29412 |
| K093185 | DIROS TECHNOLOGY, INC. |
232 HOOD ROAD | MARKHAM, ONTARIO | L3R 3K8 | |
| K062758 | DIROS TECHNOLOGY, INC. |
232 HOOD ROAD | MARKHAM, ONTARIO | L3R 3K8 | |
| K941823 | ELEKTA INSTRUMENTS, INC. |
8 EXECUTIVE PARK WEST | ATLANTA | GA | 30329 |
| K010202 | LESLIE W. ORGAN |
1837 KEMPTON RD. | CHARLESTON | SC | 29412 |
| K111576 | NEUROTHERM, INC. |
200 Homer Ave | Ashland | MA | 01721 |
| K052878 | NEUROTHERM, INC. |
2 DEBUSH AVE. BUILDING A2 | MIDDLETON | MA | 01949 |
| K040565 | PHYSICIAN INDUSTRIES, INC. |
3395 WEST 1820 SOUTH | SALT LAKE CITY | UT | 84104 |
| K963577 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K982489 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K965182 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K171143 | Relievant Medsystems |
2688 Middlefield Road, Suite A | Redwood City | CA | 94063 |
| K220122 | RF Innovations, Inc |
30 Log Bridge Road | Middleton | MA | 01949 |
| K983214 | RITA MEDICAL SYSTEMS |
967 NORTH SHORELINE BLVD. | MOUNTAIN VIEW | CA | 94043 |
| K070336 | STOCKERT GMBH |
BOETZINGER STRASSE 72 | FREIBURG, B-W | D-79111 | |
| K170242 | STRYKER CORPORATION |
4100 E. MILHAM AVE | KALAMAZOO | MI | 49001 |
| K010969 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K071482 | SYNERGETICS, INC |
3845 CORPORATE CENTRE DRIVE | O'FALLON | MO | 63368 |
| K063489 | SYNERGETICS, INC. |
3600 HORIZON DRIVE | VALLEY FORGE | PA | 19406 |
| K032601 | VALLEY FORGE SCIENTIFIC CORP. |
136 GREEN TREE RD. | OAKS | PA | 19456 |
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