FDA 510(k) Applications for Medical Device:
Clamp, Umbilical

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K021055 BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 2156
HUNTINGTON CT 06484
K010835 BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR.
HAUPPAUGE NY 11788
K012917 DYNAREX CORP. 7736 WOODSIDE COURT
MAINEVILLE OH 45039
K974227 GPS 11 LOWELL RD.
PORT WASHINGTON NY 11050
K983204 HARWILL MEDICAL (PTY) LTD. P O BOX 4341
CROFTON MD 21114
K033846 KAEN YIH ENTERPRISE CO., LTD. 1202 S. RTE. 31
MCHENRY IL 60050
K041332 MATERNUS, INC. 15303 HUEBNER RD., BLDG. 10
SAN ANTONIO TX 78248
K010695 MATERNUS, INC. 13223 HUNTERS LARK
SAN ANTONIO TX 78230
K011621 MATERNUS, INC. P.O. BOX 782089
SAN ANTONIO TX 78278
K994367 MEDICAL SALES CO. P.O. BOX 540314
NORTH SALT LAKE UT 84054
K963223 PHYLLIS ADAMS, RN, NPC, MSN 27 LADY DIANA CIRCLE
MARLTON NJ 08053
K000227 POLLAK (INTL.), LTD. HAMLACHA 20, INDUSTRIAL ZONE
ROSH HA'AYIN 48091
K990737 PRECISION DYNAMICS CORP. 13880 DEL SUR ST.
SAN FERNANDO CA 91340-3490
K020718 PRECISION DYNAMICS CORP. 13880 DEL SUR ST.
SAN FERNANDO CA 91340-3490
K994263 PRECISION DYNAMICS CORP. 13880 DEL SUR ST.
SAN FERNANDO CA 91340-3490
K963889 QFC INDUSTRIES 2405 FOREST PARK BLVD.
FORT WORTH TX 76110-1765
K963428 R.O.S.T. MEDICAL DEVELOPMENT, INC. 11800 28TH ST., NORTH
ST. PETERSBURG FL 33716




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