FDA 510(k) Applications for Medical Device:
Bath, Hydro-Massage
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K082951 | ARJO HOSPITAL EQUIPMENT AB |
50 NORTH GARY AVENUE, SUITE A | ROSELLE | IL | 60172-1684 |
| K001079 | ARJO, INC. |
50 NORTH GARY AVE., SUITE A | ROSELLE | IL | 60172-1684 |
| K110994 | ARJOHUNTLEIGH INC |
2349 WEST LAKE STREET | ADDISON | IL | 60101 |
| K980920 | BOUVIER HYDRO, INC. |
100 WALNUT ST. SUITE 20 | CHAMPLAIN, | NY | 12919 |
| K980909 | BOUVIER HYDRO, INC. |
100 WALNUT ST. SUITE 20 | CHAMPLAIN, | NY | 12919 |
| K052479 | ENNEKING MEDICAL INC. |
1801 GUINOTTE AVE. | KANSAS CITY | MO | 64120 |
| K980033 | FERNO-WASHINGTON, INC. |
70 WEIL WAY | WILMINGTON | OH | 45177 |
| K964926 | JOERNS HEALTHCARE, INC. |
5001 JOERNS DR. | STEVENS POINT | WI | 54481-5040 |
| K992779 | MEDI-MAN REHABILITATION PRODUCTS, INC. |
6200 TOMKEN ROAD | MISSISSAUGA, ONTARIO | L5T 1X7 | |
| K991184 | NATS CORP. |
30 NORTHPORT RD. | SOUND BEACH | NY | 11789-1734 |
| K974321 | NORTH AMERICAN TECHNICAL SERVICES CORP. |
30 NORTHPORT RD. | SOUND BEACH | NY | 11789-1734 |
| K012057 | PENNER MANUFACTURING, INC. |
1500 WOODMEN TOWER | OHAHA | NE | 68102 |
| K040772 | PENNER MANUFACTURING, INC. |
1500 WOODMEN TOWER | OHAHA | NE | 68102 |
| K012061 | PENNER MANUFACTURING, INC. |
1500 WOODMEN TOWER | OHAHA | NE | 68102 |
| K971593 | THE SILCRAFT CORP. |
555 THIRTEENTH ST., N.W. | WASHINGTON | DC | 20004-1109 |
| K971592 | THE SILCRAFT CORP. |
555 THIRTEENTH ST., N.W. | WASHINGTON | DC | 20004-1109 |
| K993872 | VANCARE, INC. |
1515 1ST ST. | AURORA | NE | 68818 |
| K980769 | WINDMERE CORP. |
30 NORTHPORT RD. | SOUND BEACH | NY | 11789-1734 |
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