FDA 510(k) Applications for Medical Device:
Kit, Repair, Catheter, Hemodialysis

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K011015 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K022561 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K030442 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K063446 C.R. BARD, INC. 5425 WEST AMELIA EARHART DR.
SALT LAKE CITY UT 84116
K101261 C.R. BARD, INC. 605 N 5600 W
SALT LAKE CITY UT 84116
K020430 DIATEK, INC. 101 N. CHESTNUT ST. #300
WINSTON-SALEM NC 27101
K092797 KENDALL 15 HAMPSHIRE ST.
MANSFIELD MA 02048
K022570 MEDCOMP 1499 DELP DR.
HARLEYSVILLE PA 19438
K011576 MEDICAL COMPONENTS, INC. 1499 DELP DR.
HARLEYSVILLE PA 19438
K062435 SPIRE BIOMEDICAL, INC. ONE PATRIOTS PARK
BEDFORD MA 01730-2396
K022644 SPIRE BIOMEDICAL, INC. ONE PATRIOTS PARK
BEDFORD MA 01730-2396




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact