FDA 510(k) Applications for Medical Device:
System, Applicator, Radionuclide, Manual

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K973638 AVID N.I.T., INC. 390 SCARLET BLVD.
OLDSMAR FL 34677
K973037 AVID N.I.T., INC. 390 SCARLET BLVD.
OLDSMAR FL 34677
K972554 AVID N.I.T., INC. 917 KLOSTERMAN RD. EAST
TARPON SPRINGS FL 34689
K951052 DUKE UNIVERSITY MEDICAL CENTER BOX 3010
DURHAM NC 27710
K010166 IMAGYN MEDICAL TECHNOLOGIES, INC. 8850 M-89
RICHLAND MI 49083
K961377 MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR.
NORTHBROOK IL 60062
K963743 MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR.
NORTHBROOK IL 60062
K973786 NW RADIATION THERAPY PRODUCTS 5245 SHILSHOLE AVENUE NW,
SEATTLE, WA 98107
K980997 PGK, INC. 8320 OLD COURTHOUSE RD.
VIENNA VA 22182
K973184 PROMEX, INC. 1125 BROOKSIDE AVE.
INDIANAPOLIS IN 46202
K974118 WORLDWIDE MEDICAL TECHNOLOGIES, LLC 125 MAIN ST., NORTH
WOODBURY CT 06798-0505




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