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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 |
|---|---|---|---|---|---|
| K961060 | ARISTO MEDICAL PRODUCTS, INC. |
P.O. BOX 1637 | WAUKESHA | WI | 53187-2345 |
| K973839 | CATHETER RESEARCH, INC. |
6131 WEST 80TH ST. | INDIANAPOLIS | IN | 46278 |
| K072621 | CINCINNATI SUB-ZERO PRODUCTS, INC |
12011 MOSTELLER ROAD | CINCINNATI | OH | 45241 |
| K193027 | DeRoyal Industries, Inc. |
200 DeBusk Lane | Powell | TN | 37849 |
| K062020 | NOVAMED, LLC |
3460 POINTE CREEK CT. #102 | BONITA SPRINGS | FL | 34134-2015 |
| K982193 | SHORE MEDICAL, INC. |
2037 OAK GLEN DR. | VISTA | CA | 92083 |
| K111050 | STARBOARD MEDICAL, LLC |
22845 SAVI RANCH PKWY | Yorba Linda | CA | 92887 |
| K140134 | STARBOARD MEDICAL, LLC |
22845 Savi Ranch Pkwy Ste H | Yorba Linda | CA | 92887 |
| K092716 | TRUER MEDICAL INC. |
1050 N BATAVIA STREET | ORANGE | CA | 92867 |