FDA 510(k) Applications for Medical Device:
Pack, Hot Or Cold, Disposable

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K973770 ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K
MCGRAW PARK IL 60085
K982652 ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K
MCGRAW PARK IL 60085
K970399 ALLEGIANCE HEALTHCARE CORP. 1660 IOWA AVE., SUITE 100/200
RIVERSIDE CA 92507
K021843 BIO-LIPID, INC. 1301 K STREET, N.W.
WASHINGTON DC 20005
K082087 BIO-LIPID, INC. 1700 PENNSYLVANIA AVE., NW
WASHINGTON DC 20006
K951033 CANDELA LASER CORP. 530 BOSTON POST RD.
WAYLAND MA 01778
K960624 CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT
KANSAS CITY MO 64127
K974190 CONSOLIDATED PRODUCTS & SERVICES, INC. 100-L MESSINA DR.
BRAINTREE MA 02184
K112547 DENOVO PROUCTS LLC 17051 ALICO COMMERCE CT. #3
FT. MYERS FL 33967
K980509 DEROYAL INDUSTRIES, INC. 200 DEBUSK LN.
POWELL TN 37849
K963689 FLORIDA MEDICAL INDUSTRIES, INC. 40178 U.S. 19 NORTH
TARPON SPRINGS FL 34689
K221653 International Biomedical 8206 Cross Park Drive
Austin TX 78754
K071710 JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. 201 TABOR ROAD
MORRIS PLAINS NJ 07950
K963666 KICK ICE, INC. P.O. BOX 5519 EKS
JOHNSON CITY TN 37603
K963768 KICK ICE, INC. P.O. BOX 5519 EKS
JOHNSON CITY TN 37603
K955788 OMNI THERM, INC. 2338 WELDON PKWY.
ST. LOUIS MO 63146
K954877 OMNI THERM, INC. 2338 WELDON PKWY.
ST. LOUIS MO 63146
K961176 OMNI THERM, INC. 2338 WELDON PKWY.
ST. LOUIS MO 63146
K163295 RAPID AID CORP. 4120 A SLADEVIEW CRESENT
MISSISSAUGA L5L 5Z3
K963220 TEMPO TECHNOLOGY, INC. 5945 NORTH WASHINGTON BLVD.
SARASOTA FL 34243




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