FDA 510(k) Applications for Medical Device:
Infant Heel Warmer (Chemical Heat Pack)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K961154 | BAXTER HEALTHCARE CORP. |
1500 WAUKEGAN RD. | MCGAW PARK | IL | 60085 |
| K151845 | COOPERSURGICAL, INC. |
95 CORPORATE DR. | TRUMBULL | CT | 06611 |
| K954716 | DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K103549 | DENOVO PRODUCTS LLC |
17051 Alico Commerce Court | Fort Myers | FL | 33967 |
| K964523 | FLORIDA MEDICAL INDUSTRIES, INC. |
40178 U.S. 19 NORTH | TARPON SPRINGS | FL | 34689 |
| K221154 | International Biomedical |
8206 Cross Park Drive | Austin | TX | 78754 |
| K032989 | MEDIHEAT, INC. |
505 HILL ROAD | DALTON | GA | 30722 |
| K150627 | RAPID AID CORP. |
4120 A SLADEVIEW CRESENT | MISSISSAUGA | L5L 5Z3 | |
| K040856 | RAPID AID LTD. |
4120 A SLADEVIEW CRESENT | MISSISSAUGA, ONTARIO | L5L 5Z3 | |
| K040044 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K053254 | SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. |
12390 EAST END AVENUE | CHINO | CA | 91710 |
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